The American College of Foot and Ankle Surgeons’ revised guidelines for heel pain treatment reflect lower extremity healthcare’s increasing focus on evidence-based medicine, including hundreds of references as well as helpful diagrams. But evidence has its limitations, and clinical experience is still essential to the therapeutic process.
New practice guidelines for the diagnosis and treatment of heel pain, published on April 30 by the American College of Foot and Ankle Surgeons (ACFAS), continued the trend of basing treatment recommendations on evidence-based medicine.1 But the guidelines also provoked controversy among those most likely to rely on them for clinical decision making.
Heel pain—most commonly plantar fasciitis—is a serious matter for podiatrists, physical therapists, and other lower extremity clinicians. Roughly two million Americans are affected by it each year, and 10% of people experience chronic heel pain at some point in their lives.2
Despite the condition’s prevalence, practitioners disagree about the best treatments for it. Some of this has to do with scope of practice; physical therapists can’t give cortisone injections or perform surgery, of course, and podiatrists are usually less familiar with physical therapy approaches than with the techniques in which they’ve been trained. Some clinicians dismiss the relevance of orthoses, while others consider them the most crucial aspect of treatment. Certain practitioners feel that surgery is inappropriate for fasciitis, while others rely on it to an extent that their colleagues sometimes consider troubling.
Of course, the whole point of guidelines is to delineate the evidence for different approaches and help all practitioners make better decisions. And although there is significant confluence of ideas about best practices, the differences can be telling. The American Physical Therapy Association (APTA) published its own set of heel pain guidelines in 2008 and provided significant evidence for its recommendations.3 And although the APTA recommendations agree in many respects with the ACFAS guidelines, the two documents also diverge in important ways.
Both organizations rank evidence and make recommendations based on the same template, though they differ in the details. Evidence is graded from Level I (the highest, based on randomized controlled trials) to Level IV or V (expert opinion). Grades of recommendation range from grade A (strong evidence, based on Level I or II studies) to grade F (in the case of the APTA guidelines) or grade I (in the ACFAS guidelines, “I” signifies “insufficient evidence to make a recommendation”).
The Word from ACFAS
The new ACFAS guidelines, which evolved from a previous version in 2001,4 classify heel pain in several categories and provide both text and graphic pathways for diagnosing, evaluating, and treating it. The clinician’s first step is to determine the cause of the problem, whether it be neurologic, arthritic, traumatic, or mechanical. This last etiology, which typically presents as plantar heel pain, is the most common.
“What’s really new in these guidelines is they are not just opinion-based; we’ve tried to look at evidence-based medicine and give treatment recommendations based on that,” said James Thomas, DPM, FACFAS, the lead author of the ACFAS guidelines.
Thomas, an associate professor in the department of orthopedics at West Virginia University in Morgantown, noted other improvements over the previous version.
“Newer technology and treatments are available now, such as radiofrequency coblation of the plantar fascia, though at this point it rates only a ‘C’ because it’s so new we don’t have the numbers to support it,” he said. “We will probably see that [literature] grow over the next few years.”
The new guidelines also note a shift in terminology.
“While ‘fasciitis’ describes the most common cause of heel pain, MRI studies are showing us that it is not just a matter of inflammation,” Thomas said. “There are degenerative changes in the fascia which are better described as ‘fasciosis.’ Practitioners recognize this and are starting to use the new term.”
Thomas also pointed out the document’s flowcharts, which provide a succinct visual presentation of the decision trees in the text. In Pathway 2, “Plantar Heel Pain,” for example, clinicians are guided through taking the history (e.g., pain in the morning or after periods of rest); through significant findings (radiographs, pain on palpation, obesity, pronated foot architecture, and the like); through initial treatment options (e.g. stretching, over the counter insoles, cortisone injection, activity limitation, padding, and strapping); and finally to second and third-tier treatments that include night splints, prescription orthoses, repeated injections, and surgery.
Controversy
Some of these recommendations have stirred the pot of controversy, however. For example, corticosteroid injections are given an evidence grade of B in the guidelines’ text and listed as an initial treatment option; by contrast, physical therapy is not listed in any of the protocol’s three tiers (physical therapy received a grade of “I”—insufficient evidence to recommend—from ACFAS).
“I am strongly against cortisone shots as a first intervention,” said Michael Gross, PT, PhD, a professor of physical therapy at the University of North Carolina at Chapel Hill. “They don’t address a single issue that gave the person the problem. Fasciitis is caused by tensile stress from the foot undergoing three-point bending, exacerbated by factors such as weight gain or increases in activity. An injection compromises tissue that is already weak, and it reduces pain that is the only thing telling the patient that something’s wrong. As a result, they’re likely to go out and hurt the tissue more, but they won’t know that until the analgesic wears off, at which point they’re in worse condition than they were originally.”
It’s not only physical therapists who object to this treatment approach.
“I would take exception to corticosteroids being in Tier 1, for a first visit,” said James Clough, DPM, who practices in Great Falls, MT. “There are people who come in with such severe pain that they can’t walk, and maybe there I would occasionally give an injection. But 95% of patients never need that. You’re running the risk of injuring Baxter’s nerve and creating a neuritis, and corticosteroids delay the healing process. Also, some studies have suggested the method of injection is more important than what is actually injected.”
Thomas acknowledged that clinical judgment should be a key factor in such decisions.
“With clinical practice guidelines you have to be inclusive and consider all the different types of presentation you may see,” he responded. “The panel agreed that corticosteroid injections have to be used judiciously, and by no means do we use them now as we did ten years ago, when patients would get a series of three weekly injections. By the same token, we don’t have evidence-based medicine that says, ‘What is the proper time for that?’ An injection in the first appointment would be for the patient who has had problems for a long time and is acutely symptomatic.”
Reprinted with permission from Thomas JL, Christensen JC, Kravitz SR, et al. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg 2010;49(3 Suppl):S2.
Although Thomas emphasized the importance of examining the guidelines’ text rather than going just by the flowcharts, in fact the text provides no further clarification of the authors’ intent in this matter. It simply reads, “Initial treatment options may include…a corticosteroid injection localized to the area of maximum tenderness.” The guidelines from nine years ago read, “Initial treatment options may include…corticosteroid injections for appropriate patients.”4 It’s difficult to discern the change in approach.
Some research supports concern. For example, a 2005 paper in the Clinical Journal of Sports Medicine found that “existing medical literature does not provide precise estimates for complication rates….Tendon and fascial ruptures are often reported complications of injected corticosteroids.”5
Necessary Surgery?
Clough also expressed concern that the guidelines did not clarify which aspects of orthotic intervention were most likely to affect fasciitis.
“Fasciitis is primarily a mechanical malfunction of the foot, and the orthotic, along with stretching and gait training, is very important in establishing normal function,” he said. “But the ACFAS guidelines don’t expound on what an orthotic approach should be. Almost 100% of my plantar fasciitis patients are not walking correctly, and a lot of that has to do with dysfunction of the first ray. Correcting that with an orthotic modification, then doing the appropriate gait training to get them to use their first ray and engage the windlass mechanism, is a very effective way to treat fasciitis.”
Clough has not had to resort to plantar fascia surgery for fasciitis in his past 15 years of practice, and he is troubled at how often some of his colleagues do.
“I worry that we are going too fast from Tier 1 to Tier 2, then to Tier 3,” he said. “Not all doctors adhere to these tiers. They don’t understand the proper use of orthotics, stretching, and gait training; they view them as just another stepping stone to surgery. This is a mechanically induced problem, and if patients are not responding to mechanical control of the foot, we need to reevaluate and make changes. Watching your patients walk can be very instructive. Perhaps surgery is appropriate for hallux limitus or an extremely unstable flatfoot deformity, but I fail to see the indication for a plantar fasciotomy, no matter how many ways you can think of to do it.”
Thomas agreed that roughly 95% of patients get better without surgery.
“In the algorithms we recommend exhaustive nonoperative care for a minimum of six months,” he said. “Surgery is really the end stage, only if you’ve failed nonoperative approaches. But it is very worthwhile for folks who have gotten to that point and has a high success rate, approaching 90%.”
However, Clough noted a scarcity of studies assessing long-term outcomes following plantar fasciotomy.
“Is there an increase in bunion deformities, in hammer toes, in shin splints? Is there a flattening of the foot?,” he asked. “You look at them after a year and you say, ‘they got better.’ But five years down the line are they still better, or are they coming in with other problems?”
Some research supports Clough’s concerns, including at least one long-term study. In 2009, researchers reviewed 22 years’ worth of studies, then reported in the Journal of the American Podiatric Medical Association that research in cadaver feet suggested that plantar fasciotomy led to loss of integrity of the medial longitudinal arch. They also reviewed in vivo studies, which found satisfactory clinical outcomes but a decrease in medial longitudial arch height and a medial deviation of the center of pressure of the weightbearing foot.6 One long-term study of fasciotomy (4.5- to 15-year follow-up) reported that it was successful (i.e., with good or excellent results) 71% of the time, but that problems included slower recovery and abnormalities of foot function.7
The PT’s Perspective
The authors of the APTA guidelines, not surprisingly, found significant evidence to support the use of physical therapy in treating heel pain and fasciitis (though it should be noted that an MD was among the authors).
Recommendations for the physical exam include palpation, talocural joint dorsiflexion range of motion, the tarsal tunnel syndrome test, the windlass test, and longitudinal arch angle. Interventions include activity limitation, dexamethasone delivered via iontophoresis, manual therapy, stretching of the calf and plantar fascia, night splints, and prefabricated or custom foot orthoses.
“We wanted to review the best current evidence for how one should go about the exam, and also look at interventions that fall within the realm of physical therapy,” said Thomas McPoil, PT, PhD, lead author of the guidelines. McPoil, who is the regents professor of physical therapy and co-director of the Laboratory for Foot and Ankle Research at Northern Arizona University in Flagstaff, added that the authors had hoped to include exercise but ultimately opted not to.
“Most physical therapists feel that exercise is important, for both the muscles of the lower leg and the intrinsic muscles of the foot, but we didn’t have the evidence to substantiate including that,” he said.
A recent randomized clinical trial further bolstered the efficacy of manual therapy, however;2 and Michael Gross explained why stretching the calf actually works.
“When you get a lot of tension in the Achilles, it grabs onto the calcaneus and pulls it slightly posterior, which stretches the plantar fascia,” he said. “And if you have tightness in the calf muscles, it will restrict the motion of the ankle joint and drive it to the other joints of the foot. That, in turn, can cause the arch to collapse and put even more stress on the plantar fascia.”
“What is preventing our patients from doing what they want to do is edema, inflammation of periarticular tissues, muscle weakness, and pain,” McPoil added. “In physical therapy, we have to look more at impairment, functional limitation, and disability rather than trying to come up with a specific diagnosis.”
McPoil’s colleague and coauthor, Mark Cornwall, PT, PhD, CPed, agreed. “Plantar fasciitis is a medical diagnosis, not a physical therapy diagnosis,” Cornwall said. “The physical therapist would say, ‘I know you have fasciitis, but what can you do? What can’t you do? Why can’t you do it?’”
According to McPoil, the feedback from therapists has been positive.
“It’s having an impact,” he said. “Physical therapists like the guidelines because it provides a consensus of the available literature. They can say, here is what we’re doing, and here’s the evidence to support that.”
New studies make it important to update the guidelines every four or five years if possible, McPoil said; the 2008 guidelines are the first set issued by the APTA. He is also more struck by the similarities between the various guidelines than by their differences.
“If you allow for the differences in scope of practice, the new guidelines from ACFAS are very similar to what we published,” he said. “I was glad to see that, because I thought, good—we are pretty much right on.”
Cary Groner is a freelance writer based in the San Francisco Bay area.
References
1. Thomas JL, Christensen JC, Kravitz SR, et al. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg 2010;49(3 Suppl):S1-19.
2. Cleland JA, Abbott JH, Kidd MO, et al. Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther 2009;39(8):573–585.
3. McPoil TG, Martin RL, Cornwall MW, et al. Heel pain—plantar fasciitis: clinical practice guidelines. J Orthop Sports Phys Ther 2008;4(38):A1–18.
4. Thomas JL, Christensen JC, Kravitz SR, et al.The diagnosis and treatment of heel pain. J Foot & Ankle Surg 2001;40(5):329–340.
5. Nichols A. Complications associated with the use of corticosteroids in the treatment of athletic injuries. Clin J Sport Med 2005;15(5):370–375.
6. Tweed JL, Barnes MR, Allen MJ, Campbell JA. Biomechanical consequences of total plantar fasciotomy: a review of the literature. J Am Podiatr Med Assoc 2009;99(5):422–430.
7. Daly P, Kitaoka H, Chao E. Plantar fasciotomy for intractable plantar fasciitis: clinical results and biomechanical evaluation. Foot Ankle 1992;13(4):188–195.
Tuesday, October 18, 2011
Monday, October 17, 2011
Socks: Getting in shape with new technologies
Socks are often an afterthought for patients with diabetes, but they shouldn’t be. Advances in materials science and new twists on old favorites mean that modern socks conform to feet without the bunching, chafing, slipping, and irritation of the past. Some even promote healing.
Socks have come a long way since the days of the long white tube with the colored bands around the top. A visit to any sporting goods store will offer a rock climbing wall’s worth of “performance socks,” tricked out with high-tech properties such as moisture wicking, temperature control, and arch support.
No doubt that these sock manufacturers have taken more than a few cues from diabetic socks, which have always combined fibers to maximize support, cushioning, and comfort. But do diabetic socks offer advantages to patients beyond these performance socks? Yes and no, according to the experts. Proper fit and sizing play a big part in ensuring that diabetic socks do their job.
Materials
One hundred percent cotton or wool socks have been criticized for not maintaining the sock’s shape on the foot, which can be problematic for diabetic patients on two fronts. The increased friction between the skin and the fibers can lead to ulcerations. In addition, 100% cotton or wool socks may start out quite tight, possibly reducing circulation in patients who already have compromised blood flow. As the socks are worn over time, the fibers loosen, resulting in a sock that slides between the foot and the shoe, again leaving diabetic patients vulnerable to shear, blisters, and potential ulcerations.
On the other hand, purely synthetic socks may not allow sweat to evaporate properly; sweaty feet can lead to fungal infections, which in and of itself is more complicated in a patient with diabetes than an otherwise healthy subject and can also be another gateway to ulceration. Synthetics blended with natural fibers would seem to be the best bet, offering support and—most importantly—breathing room, according to Marybeth Crane, MS, DPM, FACFAS, CWS, managing partner of Foot and Ankle Associates of North Texas in Grapevine.
“I’m not one that really likes totally cotton socks,” she said. “I find that socks with a little bit of Lycra in them are better. They also offer some compression to address swelling.”
Crane also advocates seamless socks because seams, constantly rubbing against the skin, may cause blisters, calluses, or ulcerations. For a patient with neuropathy, a skin irritation caused by the seam will not be felt immediately, increasing the risk of calluses and other pre-ulcerative conditions.
Moisture wicking can be achieved with a variety of materials: Wool, synthetics, cotton, silk, and renewable materials. Each has its pros and cons.
The biggest advantage of wool, and merino wool in particular, is that it is thermostatic so that feet stay comfortable in a range of temperatures. Wool also can absorb 30% of its own weight in water so feet are more likely to stay dry. Cushioning is another benefit, because diabetic patients have an increased risk for pressure ulcers and because focused areas of high plantar pressure are most likely to become sites of ulceration. On the downside, wool dries out slowly, and wool socks generally carry a higher price-tag than other materials. Both factors could prove problematic for a diabetic patient who cannot afford multiple pairs of socks.
Synthetics, such as nylon and Lycra spandex, help socks retain their shape. Some synthetics may provide arch support, which can help lateralize plantar pressures and provide a bit of extra stability for diabetic patients who have problems with balance. Socks with polypropylene, polyester, or acrylic fibers will offer moisture wicking. Synthetic socks are durable but may be unsuitable for warmer climates. In addition, the socks’ insulation properties may be reduced if the socks get too wet.
Silk is a natural insulator that is often blended with wool for extra softness. The lightweight material offers reliable wicking and a smooth texture; however, it is less durable than other materials. This is important not only with regard to the cost and inconvenience of replacing socks, but also because areas of wear in a sock’s fabric fail to protect the diabetic foot and leave skin vulnerable. In addition, the very “silkiness” of a silk-based material could cause the foot to slip within the shoe, leading to abnormal skin shear and friction-induced skin issues.
A full cotton sock is not advisable for the diabetic foot. The material is easily saturated with sweat and dries slowly, both of which leave the foot vulnerable to blisters. Cotton is less expensive than other materials and, when blended in small quantities with synthetics, it can offer softness.
Eco-friendly materials, such as bamboo, corn-based polylactic acid (PLA), hemp, and charcoal, offer moisture wicking and odor control properties. Combining these materials with synthetic fabrics ups their durability.
Finally, socks made of fabrics embedded with copper, silver, or charcoal fibers offer protection against bacteria. Patients with diabetes are less resistant than healthy individuals to infection, which can lead to complications such as cellulitis (diffuse inflammation of the connective tissue) or osteomyelitis (bone infection, which almost always occurs in the presence of an ulcer). However, a sock billed as resisting bacterial growth does not automatically reduce the chance of infections on the surface of the foot, nor will this type of fabric necessarily protect an open wound from becoming infected. Visual inspection of the feet, along with daily washing, is still needed to avoid infection.
Socks come in sizes
While it’s obvious to patients with diabetes that their shoes come in sizes, the same cannot always be said for socks.
“A lot of patients don’t realize that their socks need to be the correct size,” Crane said. “If the sock is too tight, it can cause ingrown toenails, it can cause problem with compression in between the toes, it can cause ulceration between the toes.”
Crane said she advices her patients with diabetes to “size up” when it comes to socks.
“For instance, I wear a size 6-6.5 (in shoes) and most size small socks go to 6. I’ll go to a medium sock instead of a small because they will shrink once they are washed,” she said.
Socks that are too tight can reduce flow, which is particularly problematic in patients whose diabetes is complicated by vascular disorders. Poor blood flow impairs healing of existing ulcers and other wounds; it can exacerbate loss of sensation in neuropathic patients, increasing the risk of neuropathic ulcers; and it can also increase the risk of ischemic ulcers, which are even more difficult to heal. However, socks that are too big can wrinkle or bunch inside the shoe, putting excess pressure on the feet. For patients with neuropathy, a bunched sock can easily lead to blisters or ulcerations.
But as with shoes, neuropathic patients often need a sock to feel snug against their leg. A sock with binding elastic at the top may feel right to these patients, but can negatively impact blood flow.
If possible, socks and shoes should be fit simultaneously, Crane added.
“One of my pet peeves is that the socks and shoes are not fit at the same time,” she said. “I have a patient who has a beautiful pair of diabetic shoes, but she wears them with pantyhose that she buys at the drug store. The hose have a seam in them and that causes an ulceration on the tip of her toe.”
Another argument for fitting shoes and socks simultaneously is that once a sock size has been determined, the shoe size may change. For instance, a neuropathic patient who is prescribed a therapeutic sock with silicone padding to reduce plantar pressure may have to go with a shoe that is a half-size larger or convert to extra-depth shoes.
OTS socks
Crane pointed out that socks are not covered under the Therapeutic Shoe Bill (see HEADLINE, PAGE XX) so they are an out-of-pocket expense for the patient.
“Good socks are expensive,” she said. “You can’t buy a good pair of socks for $4. You are looking at as much as $20.”
As a result, off-the-shelf (OTS) socks are not always out of the question.
“In terms of the OTS, performance socks, I like the ones that have a bit of Lycra and a bit of either DryWeave or CoolMax to wick the sweat away from the foot. That’s necessary whether the person is a diabetic or not,” she said.
But these performance socks don’t necessarily offer the kind of support that a diabetic foot requires, pointed out Roy H. Lidtke DPM, CPed, FACFAOM, associate professor of podiatric medicine and surgery at Des Moines University and director of the Center for Clinical Biomechanics at
St. Luke’s Hospital, Cedar Rapids, IA. Socks made especially for patients with diabetes provide that support, along with added benefits.
“They offer extra padding and compression that can produce a form of neuromuscular feedback,” Lidtke said. “An example would be when you wear a pair of padded socks with areas of elastic compression and you feel a tightness around your arch. This provides greater proprioceptive feedback on the position and neuromuscular control of the foot.”
Diabetes is often complicated by a loss of postural control, which research suggests is a product of more than just the loss of sensation that accompanies neuropathy. Any intervention that can improve proprioception could potentially also help to improve postural control and, in turn, reduce patients’ risk of falling.
Shedding light on neuropathic pain
Advances in materials technology have seen the introduction of socks with optically modified properties.
Both near infrared light and far infrared light have shown efficacy in addressing diabetic foot problems by influencing the transmission of electromagnetic energy into the underlying tissue and skin. When incorporated into socks, near and far infrared light are credited with improving blood flow, delivering more oxygen to the tissues, and reducing swelling.
A recent study done at the University of California, Irvine looked at the effect of polyethylene terephthalate fiber socks on foot pain in patients with diabetic neuropathy and other disorders. In this double-blinded, randomized trial, 55 patients (29 with diabetic neuropathy) wore socks made from polyethylene terephthalate (PET) incorporating optically active particles (Celliant). The latter scatters and reflects visible light and near infrared light, according to the study authors.
Overall, patients reported a certain level of pain reduction. In the neuropathic patients, there was some some pain reduction but it was not as significant as it was in the patients with other foot disorders. The authors postulated that in the neuropathic foot, only a portion of the diseased neuron fibers are in close proximity to the sock. The findings were published in April 2009 by the online journal BMC Complementary and Alternative Medicine.
Far infrared and negative ion technology, which also can be incorporated in sock fibers, has been shown to reduce some of the foot discomfort associated with neuropathy. Although no studies of far-infrared socks have been published in the medical literature to date, a recent randomized clinical trial did evaluate the effects of photon stimulation with far infrared light on pain intensity and pain relief in patients with diabetic peripheral neuropathy.
Patients who underwent a series of photon therapy treatments reported significant decreases in the intensity and quality of their pain, with a 30% to 50% reduction in pain immediately following treatment, compared to those who received a placebo treatment. The findings were published in the January 2010 issue of the Journal of Pain and Symptom Management.
By Shalmali Pal
Socks have come a long way since the days of the long white tube with the colored bands around the top. A visit to any sporting goods store will offer a rock climbing wall’s worth of “performance socks,” tricked out with high-tech properties such as moisture wicking, temperature control, and arch support.
No doubt that these sock manufacturers have taken more than a few cues from diabetic socks, which have always combined fibers to maximize support, cushioning, and comfort. But do diabetic socks offer advantages to patients beyond these performance socks? Yes and no, according to the experts. Proper fit and sizing play a big part in ensuring that diabetic socks do their job.
Materials
One hundred percent cotton or wool socks have been criticized for not maintaining the sock’s shape on the foot, which can be problematic for diabetic patients on two fronts. The increased friction between the skin and the fibers can lead to ulcerations. In addition, 100% cotton or wool socks may start out quite tight, possibly reducing circulation in patients who already have compromised blood flow. As the socks are worn over time, the fibers loosen, resulting in a sock that slides between the foot and the shoe, again leaving diabetic patients vulnerable to shear, blisters, and potential ulcerations.
On the other hand, purely synthetic socks may not allow sweat to evaporate properly; sweaty feet can lead to fungal infections, which in and of itself is more complicated in a patient with diabetes than an otherwise healthy subject and can also be another gateway to ulceration. Synthetics blended with natural fibers would seem to be the best bet, offering support and—most importantly—breathing room, according to Marybeth Crane, MS, DPM, FACFAS, CWS, managing partner of Foot and Ankle Associates of North Texas in Grapevine.
“I’m not one that really likes totally cotton socks,” she said. “I find that socks with a little bit of Lycra in them are better. They also offer some compression to address swelling.”
Crane also advocates seamless socks because seams, constantly rubbing against the skin, may cause blisters, calluses, or ulcerations. For a patient with neuropathy, a skin irritation caused by the seam will not be felt immediately, increasing the risk of calluses and other pre-ulcerative conditions.
Moisture wicking can be achieved with a variety of materials: Wool, synthetics, cotton, silk, and renewable materials. Each has its pros and cons.
The biggest advantage of wool, and merino wool in particular, is that it is thermostatic so that feet stay comfortable in a range of temperatures. Wool also can absorb 30% of its own weight in water so feet are more likely to stay dry. Cushioning is another benefit, because diabetic patients have an increased risk for pressure ulcers and because focused areas of high plantar pressure are most likely to become sites of ulceration. On the downside, wool dries out slowly, and wool socks generally carry a higher price-tag than other materials. Both factors could prove problematic for a diabetic patient who cannot afford multiple pairs of socks.
Synthetics, such as nylon and Lycra spandex, help socks retain their shape. Some synthetics may provide arch support, which can help lateralize plantar pressures and provide a bit of extra stability for diabetic patients who have problems with balance. Socks with polypropylene, polyester, or acrylic fibers will offer moisture wicking. Synthetic socks are durable but may be unsuitable for warmer climates. In addition, the socks’ insulation properties may be reduced if the socks get too wet.
Silk is a natural insulator that is often blended with wool for extra softness. The lightweight material offers reliable wicking and a smooth texture; however, it is less durable than other materials. This is important not only with regard to the cost and inconvenience of replacing socks, but also because areas of wear in a sock’s fabric fail to protect the diabetic foot and leave skin vulnerable. In addition, the very “silkiness” of a silk-based material could cause the foot to slip within the shoe, leading to abnormal skin shear and friction-induced skin issues.
A full cotton sock is not advisable for the diabetic foot. The material is easily saturated with sweat and dries slowly, both of which leave the foot vulnerable to blisters. Cotton is less expensive than other materials and, when blended in small quantities with synthetics, it can offer softness.
Eco-friendly materials, such as bamboo, corn-based polylactic acid (PLA), hemp, and charcoal, offer moisture wicking and odor control properties. Combining these materials with synthetic fabrics ups their durability.
Finally, socks made of fabrics embedded with copper, silver, or charcoal fibers offer protection against bacteria. Patients with diabetes are less resistant than healthy individuals to infection, which can lead to complications such as cellulitis (diffuse inflammation of the connective tissue) or osteomyelitis (bone infection, which almost always occurs in the presence of an ulcer). However, a sock billed as resisting bacterial growth does not automatically reduce the chance of infections on the surface of the foot, nor will this type of fabric necessarily protect an open wound from becoming infected. Visual inspection of the feet, along with daily washing, is still needed to avoid infection.
Socks come in sizes
While it’s obvious to patients with diabetes that their shoes come in sizes, the same cannot always be said for socks.
“A lot of patients don’t realize that their socks need to be the correct size,” Crane said. “If the sock is too tight, it can cause ingrown toenails, it can cause problem with compression in between the toes, it can cause ulceration between the toes.”
Crane said she advices her patients with diabetes to “size up” when it comes to socks.
“For instance, I wear a size 6-6.5 (in shoes) and most size small socks go to 6. I’ll go to a medium sock instead of a small because they will shrink once they are washed,” she said.
Socks that are too tight can reduce flow, which is particularly problematic in patients whose diabetes is complicated by vascular disorders. Poor blood flow impairs healing of existing ulcers and other wounds; it can exacerbate loss of sensation in neuropathic patients, increasing the risk of neuropathic ulcers; and it can also increase the risk of ischemic ulcers, which are even more difficult to heal. However, socks that are too big can wrinkle or bunch inside the shoe, putting excess pressure on the feet. For patients with neuropathy, a bunched sock can easily lead to blisters or ulcerations.
But as with shoes, neuropathic patients often need a sock to feel snug against their leg. A sock with binding elastic at the top may feel right to these patients, but can negatively impact blood flow.
If possible, socks and shoes should be fit simultaneously, Crane added.
“One of my pet peeves is that the socks and shoes are not fit at the same time,” she said. “I have a patient who has a beautiful pair of diabetic shoes, but she wears them with pantyhose that she buys at the drug store. The hose have a seam in them and that causes an ulceration on the tip of her toe.”
Another argument for fitting shoes and socks simultaneously is that once a sock size has been determined, the shoe size may change. For instance, a neuropathic patient who is prescribed a therapeutic sock with silicone padding to reduce plantar pressure may have to go with a shoe that is a half-size larger or convert to extra-depth shoes.
OTS socks
Crane pointed out that socks are not covered under the Therapeutic Shoe Bill (see HEADLINE, PAGE XX) so they are an out-of-pocket expense for the patient.
“Good socks are expensive,” she said. “You can’t buy a good pair of socks for $4. You are looking at as much as $20.”
As a result, off-the-shelf (OTS) socks are not always out of the question.
“In terms of the OTS, performance socks, I like the ones that have a bit of Lycra and a bit of either DryWeave or CoolMax to wick the sweat away from the foot. That’s necessary whether the person is a diabetic or not,” she said.
But these performance socks don’t necessarily offer the kind of support that a diabetic foot requires, pointed out Roy H. Lidtke DPM, CPed, FACFAOM, associate professor of podiatric medicine and surgery at Des Moines University and director of the Center for Clinical Biomechanics at
St. Luke’s Hospital, Cedar Rapids, IA. Socks made especially for patients with diabetes provide that support, along with added benefits.
“They offer extra padding and compression that can produce a form of neuromuscular feedback,” Lidtke said. “An example would be when you wear a pair of padded socks with areas of elastic compression and you feel a tightness around your arch. This provides greater proprioceptive feedback on the position and neuromuscular control of the foot.”
Diabetes is often complicated by a loss of postural control, which research suggests is a product of more than just the loss of sensation that accompanies neuropathy. Any intervention that can improve proprioception could potentially also help to improve postural control and, in turn, reduce patients’ risk of falling.
Shedding light on neuropathic pain
Advances in materials technology have seen the introduction of socks with optically modified properties.
Both near infrared light and far infrared light have shown efficacy in addressing diabetic foot problems by influencing the transmission of electromagnetic energy into the underlying tissue and skin. When incorporated into socks, near and far infrared light are credited with improving blood flow, delivering more oxygen to the tissues, and reducing swelling.
A recent study done at the University of California, Irvine looked at the effect of polyethylene terephthalate fiber socks on foot pain in patients with diabetic neuropathy and other disorders. In this double-blinded, randomized trial, 55 patients (29 with diabetic neuropathy) wore socks made from polyethylene terephthalate (PET) incorporating optically active particles (Celliant). The latter scatters and reflects visible light and near infrared light, according to the study authors.
Overall, patients reported a certain level of pain reduction. In the neuropathic patients, there was some some pain reduction but it was not as significant as it was in the patients with other foot disorders. The authors postulated that in the neuropathic foot, only a portion of the diseased neuron fibers are in close proximity to the sock. The findings were published in April 2009 by the online journal BMC Complementary and Alternative Medicine.
Far infrared and negative ion technology, which also can be incorporated in sock fibers, has been shown to reduce some of the foot discomfort associated with neuropathy. Although no studies of far-infrared socks have been published in the medical literature to date, a recent randomized clinical trial did evaluate the effects of photon stimulation with far infrared light on pain intensity and pain relief in patients with diabetic peripheral neuropathy.
Patients who underwent a series of photon therapy treatments reported significant decreases in the intensity and quality of their pain, with a 30% to 50% reduction in pain immediately following treatment, compared to those who received a placebo treatment. The findings were published in the January 2010 issue of the Journal of Pain and Symptom Management.
By Shalmali Pal
Friday, October 14, 2011
Do Bariatric Surgery Patients Fare Better?
A new study in VA patients has found no survival benefit associated with bariatric surgery among older, severely obese people when compared with usual care, at least out to seven years....
Dr. Matthew L. Maciejewski, who presented the findings, stated that doctors "should counsel their patients that there are numerous significant benefits to bariatric surgery -- including the fact that it's the most effective weight-loss treatment, and it improves the control of chronic conditions and quality of life -- but there doesn't appear to be a survival benefit at nearly seven years." It is possible that there will be a survival benefit longer term, he says, and his group is continuing to follow these patients and add in others who have had surgery more recently.
The new findings contrast with those of prior studies, many of which have shown survival benefits with bariatric surgery, but most of which have examined outcomes in younger, primarily white, and female populations, said Maciejewski. But obesity-related mortality is highest in men and minority patients, who have high rates of comorbid diseases, and this is the first study that has looked at long-term survival in such high-risk patients, he points out.
In addition, in this work, statistical analyses were employed, which "represent an advance over prior work. The VA has really rich data sets, and we had body-mass-index [BMI] information on all patients, including the nonsurgical controls," information that provides for more robust results, Maciejewski explains.
Maciejewski et al conducted a retrospective, cohort study of bariatric-surgery programs in VA medical centers, including 850 veterans who underwent Roux-en-Y gastric bypass from January 2000 to December 2006. The population was 74% male, the mean age was 49.5 years, and the mean BMI was 47.4. Race/ethnicity was 78% white, 16% nonwhite, and the remainder "unknown." Mortality for these patients was compared with that of 41,244 nonsurgical controls (mean age 54.7 years, mean BMI 42, 74% male, and 77% white) from the same 12 Veteran Integrated Services Networks.
In unadjusted analyses, bariatric surgery was significantly associated with reduced mortality (hazard ratio 0.64), but in an analysis of 1694 propensity-matched patients, bariatric surgery was no longer significantly associated with reduced mortality in both unadjusted (hazard ratio 0.83) and time-adjusted (HR 0.94) Cox regressions.
Previous studies have mostly identified control patients via the use of a diagnosis code of morbid obesity, says Maciejewski, which "means they were probably not random samples of all patients eligible for surgery, and they were probably a sicker group [than those who underwent bypass], which might overstate the benefits of surgery."
The results highlight the importance of statistical adjustment and careful selection of surgical and nonsurgical cohorts, particularly during evaluation of bariatric surgery according to administrative data. The survival benefits between the bariatric surgery and control group were modest in most previous studies and so may have been attenuated if adjustment for confounders had been possible, they explain.
It will be important to continue to track this cohort to see whether any survival advantages for surgery emerge in the longer term. The fact that no survival advantage has been seen so far is perhaps "not surprising." In the only other trial to have compared bariatric surgery with "high-quality clinical data," the Swedish Obese Subjects (SOS) study, the survival benefit was not observed until a median of 13 years of follow-up.
It will also be necessary to incorporate other patients who have undergone more contemporary laparoscopic gastric banding or gastric-sleeve resections -- procedures that are being performed more and more in the VA system. "It will be important to update the results to account for those procedures," Maciejewski observes.
But, in the meantime, even though bariatric surgery is not associated with reduced mortality, many patients may still choose to undergo such procedures, "given the strong evidence for significant reductions in body weight and comorbidities and improved quality of life," the researchers conclude.
Dr. Matthew L. Maciejewski, who presented the findings, stated that doctors "should counsel their patients that there are numerous significant benefits to bariatric surgery -- including the fact that it's the most effective weight-loss treatment, and it improves the control of chronic conditions and quality of life -- but there doesn't appear to be a survival benefit at nearly seven years." It is possible that there will be a survival benefit longer term, he says, and his group is continuing to follow these patients and add in others who have had surgery more recently.
The new findings contrast with those of prior studies, many of which have shown survival benefits with bariatric surgery, but most of which have examined outcomes in younger, primarily white, and female populations, said Maciejewski. But obesity-related mortality is highest in men and minority patients, who have high rates of comorbid diseases, and this is the first study that has looked at long-term survival in such high-risk patients, he points out.
In addition, in this work, statistical analyses were employed, which "represent an advance over prior work. The VA has really rich data sets, and we had body-mass-index [BMI] information on all patients, including the nonsurgical controls," information that provides for more robust results, Maciejewski explains.
Maciejewski et al conducted a retrospective, cohort study of bariatric-surgery programs in VA medical centers, including 850 veterans who underwent Roux-en-Y gastric bypass from January 2000 to December 2006. The population was 74% male, the mean age was 49.5 years, and the mean BMI was 47.4. Race/ethnicity was 78% white, 16% nonwhite, and the remainder "unknown." Mortality for these patients was compared with that of 41,244 nonsurgical controls (mean age 54.7 years, mean BMI 42, 74% male, and 77% white) from the same 12 Veteran Integrated Services Networks.
In unadjusted analyses, bariatric surgery was significantly associated with reduced mortality (hazard ratio 0.64), but in an analysis of 1694 propensity-matched patients, bariatric surgery was no longer significantly associated with reduced mortality in both unadjusted (hazard ratio 0.83) and time-adjusted (HR 0.94) Cox regressions.
Previous studies have mostly identified control patients via the use of a diagnosis code of morbid obesity, says Maciejewski, which "means they were probably not random samples of all patients eligible for surgery, and they were probably a sicker group [than those who underwent bypass], which might overstate the benefits of surgery."
The results highlight the importance of statistical adjustment and careful selection of surgical and nonsurgical cohorts, particularly during evaluation of bariatric surgery according to administrative data. The survival benefits between the bariatric surgery and control group were modest in most previous studies and so may have been attenuated if adjustment for confounders had been possible, they explain.
It will be important to continue to track this cohort to see whether any survival advantages for surgery emerge in the longer term. The fact that no survival advantage has been seen so far is perhaps "not surprising." In the only other trial to have compared bariatric surgery with "high-quality clinical data," the Swedish Obese Subjects (SOS) study, the survival benefit was not observed until a median of 13 years of follow-up.
It will also be necessary to incorporate other patients who have undergone more contemporary laparoscopic gastric banding or gastric-sleeve resections -- procedures that are being performed more and more in the VA system. "It will be important to update the results to account for those procedures," Maciejewski observes.
But, in the meantime, even though bariatric surgery is not associated with reduced mortality, many patients may still choose to undergo such procedures, "given the strong evidence for significant reductions in body weight and comorbidities and improved quality of life," the researchers conclude.
Wednesday, October 12, 2011
Diabetes Doubles Alzheimer's Risk
People with diabetes are at increased risk of having a heart attack or stroke at an early age. But that’s not the only worry: Diabetes appears to dramatically increase a person’s risk of developing Alzheimer’s disease or other types of dementia later in life, according to a new study conducted in Japan.
In the study, which included more than 1,000 men and women over age 60, researchers found that people with diabetes were twice as likely as the other study participants to develop Alzheimer’s disease within 15 years. They were also 1.75 times more likely to develop dementia of any kind.
“It’s really important for the public health to understand that diabetes is a significant risk factor for all of these types of dementia,”says Rachel Whitmer, PhD, an epidemiologist in the research division of Kaiser Permanente Northern California, a nonprofit health-care organization based in Oakland, Calif.
Whitmer, who studies risk factors for Alzheimer’s but wasn’t involved in the new research, stresses that many questions remain about the link between diabetes and dementia. The new study was “well done” and provides“really good evidence that people with diabetes are at greater risk,” she says,“but we really need to look at other studies to find out why.”
What Factors Increase the Risk?
Diabetes could contribute to dementia in several ways, which researchers are still sorting out. Insulin resistance, which causes high blood sugar and in some cases leads to type 2 diabetes, may interfere with the body’s ability to break down a protein (amyloid) that forms brain plaques that have been linked to Alzheimer’s. High blood sugar (glucose) also produces certain oxygen-containing molecules that can damage cells, in a process known as oxidative stress.
In addition, high blood sugar—along with high cholesterol—plays a role in the hardening and narrowing of arteries in the brain. This condition, known as atherosclerosis, can bring about vascular dementia, which occurs when artery blockages (including strokes) kill brain tissue.
“Having high glucose is a stressor to the nervous system and to the blood vessels,” says David Geldmacher, MD, a professor of neurology at the University of Alabama at Birmingham. “The emerging information on Alzheimer’s disease and glucose shows us that we do need to remain vigilant on blood sugar levels as we get older.”
New and Improved Research
Studies dating back to the late 1990s have suggested that people with diabetes are more likely to develop Alzheimer’s disease and other types of dementia, but the research has been marred by inconsistent definitions of both diabetes and dementia.
The authors of the new study, led by Yutaka Kiyohara, MD, an environmental medicine researcher at Kyushu University, in Fukuoka, sought to address this weakness by using the gold standard of diabetes diagnosis, an oral glucose tolerance test. This involves giving a person a sugar-loaded drink after they have fasted for at least 12 hours, and then measuring how much glucose remains in their blood two hours later.
At the beginning of the study, the tests showed that 15% of the participants had full-fledged diabetes, while 23% had prediabetes, also known as impaired glucose tolerance.
During the next 15 years, 23% of the participants received a dementia diagnosis. Slightly less than half of those cases were deemed to be Alzheimer’s disease, with the remainder roughly split between vascular dementia and dementia due to other causes. (The diagnoses were confirmed with brain scans of living patients and brain autopsies in deceased patients.)
The link between diabetes and dementia risk persisted even after the researchers took into account several factors associated with both diabetes and dementia risk, such as age, sex, blood pressure, and body mass index.
The next step in the research, Whitmer says, will be to understand whether controlling blood sugar and reducing risk factors for type 2 diabetes also reduces dementia risk. She and her colleagues have several studies underway investigating these questions.
In the study, which included more than 1,000 men and women over age 60, researchers found that people with diabetes were twice as likely as the other study participants to develop Alzheimer’s disease within 15 years. They were also 1.75 times more likely to develop dementia of any kind.
“It’s really important for the public health to understand that diabetes is a significant risk factor for all of these types of dementia,”says Rachel Whitmer, PhD, an epidemiologist in the research division of Kaiser Permanente Northern California, a nonprofit health-care organization based in Oakland, Calif.
Whitmer, who studies risk factors for Alzheimer’s but wasn’t involved in the new research, stresses that many questions remain about the link between diabetes and dementia. The new study was “well done” and provides“really good evidence that people with diabetes are at greater risk,” she says,“but we really need to look at other studies to find out why.”
What Factors Increase the Risk?
Diabetes could contribute to dementia in several ways, which researchers are still sorting out. Insulin resistance, which causes high blood sugar and in some cases leads to type 2 diabetes, may interfere with the body’s ability to break down a protein (amyloid) that forms brain plaques that have been linked to Alzheimer’s. High blood sugar (glucose) also produces certain oxygen-containing molecules that can damage cells, in a process known as oxidative stress.
In addition, high blood sugar—along with high cholesterol—plays a role in the hardening and narrowing of arteries in the brain. This condition, known as atherosclerosis, can bring about vascular dementia, which occurs when artery blockages (including strokes) kill brain tissue.
“Having high glucose is a stressor to the nervous system and to the blood vessels,” says David Geldmacher, MD, a professor of neurology at the University of Alabama at Birmingham. “The emerging information on Alzheimer’s disease and glucose shows us that we do need to remain vigilant on blood sugar levels as we get older.”
New and Improved Research
Studies dating back to the late 1990s have suggested that people with diabetes are more likely to develop Alzheimer’s disease and other types of dementia, but the research has been marred by inconsistent definitions of both diabetes and dementia.
The authors of the new study, led by Yutaka Kiyohara, MD, an environmental medicine researcher at Kyushu University, in Fukuoka, sought to address this weakness by using the gold standard of diabetes diagnosis, an oral glucose tolerance test. This involves giving a person a sugar-loaded drink after they have fasted for at least 12 hours, and then measuring how much glucose remains in their blood two hours later.
At the beginning of the study, the tests showed that 15% of the participants had full-fledged diabetes, while 23% had prediabetes, also known as impaired glucose tolerance.
During the next 15 years, 23% of the participants received a dementia diagnosis. Slightly less than half of those cases were deemed to be Alzheimer’s disease, with the remainder roughly split between vascular dementia and dementia due to other causes. (The diagnoses were confirmed with brain scans of living patients and brain autopsies in deceased patients.)
The link between diabetes and dementia risk persisted even after the researchers took into account several factors associated with both diabetes and dementia risk, such as age, sex, blood pressure, and body mass index.
The next step in the research, Whitmer says, will be to understand whether controlling blood sugar and reducing risk factors for type 2 diabetes also reduces dementia risk. She and her colleagues have several studies underway investigating these questions.
Tuesday, October 11, 2011
Maggot Debridement Promotes Healing of Long-Standing Wounds
Maggots are an effective, low-cost salvage option to debride poorly vascularized, infected wounds in patients with diabetes, especially when vascular remediation is not possible....
Lawrence Eron, MD, infectious disease consultant at Kaiser Moanalua Medical Center and associate professor of medicine at the John A. Burns School of Medicine of the University of Hawaii in Honolulu, stated that, in addition to debriding nonviable tissue, maggots secrete bacteriostatic substances that help eradicate infections in conjunction with antibiotics. He said his talk involved a medical device, "and the device is the maggot."
Dr. Eron said that diabetic limb infections are difficult to treat with antibiotics in part because of vascular insufficiency. Maggot debridement therapy (MDT), using the larvae of the green blowfly (Lucilia sericata), not only removes necrotic tissue without affecting viable tissue but also stimulates the formation of granulation tissue.
Dr. Eron and colleagues used MDT to treat 37 patients with diabetes with complex wounds complicated by diabetic comorbidities. "In some cases, these wounds had been present for as long as 5 years and had failed multiple attempts at treatment," he said. The original wounds were abscesses, infected ulcers, and osteomyelitis with very narrow fistula tracts.
MDT consisted of applying 50 to 100 maggots to a wound, which were covered with nylon mesh fabric (similar to pantyhose) and then removed after 2 days. Clinicians then reapplied more maggots, and the cycles were repeated as necessary (median, 5 cycles; range, 1 - 30 cycles). Maggots were commercially obtained from Monarch Labs at a cost of just under $100 per treatment with 200 maggots.
The researchers defined a successful outcome as elimination of the infection, complete debridement of devitalized tissue, formation of robust granulation tissue, and greater than 50% closure of the wound. "The maggots will not totally heal the wound," Dr. Eron said. "We need other, further methods to heal the wound."
Of the 37 patients, "three quarters, roughly, achieved successful outcomes. The majority had Gram-positive infections. The Gram-positive infections seemed to do better than the Gram-negative anaerobic infections," Dr. Eron reported. The numbers were quite small, however, and a few wounds were culture-negative.
Representative Gram-positive organisms were methicillin-resistant Staphylococcus aureus, methicillin-sensitive S aureus, and group B streptococci. Patients were treated with appropriate, commonly used antibiotics, depending on the infecting organisms.
Failures occurred in patients with severe peripheral vascular disease with narrow fistulae that were not mechanically accessible after they healed after a single treatment in 3 patients with osteomyelitis, with bleeding from wounds (n = 2), or with excessive inflammation around the wound (n = 1). Pain limited treatment for 1 patient, but Dr. Eron said 5 or 6 patients responded well to acetaminophen for discomfort.
"The rest of the patients seemed to acquire, even with their peripheral neuropathy and numbness, some degree of sensation and would feel a creepy, crawly sensation, which they didn't object to," he said. "In fact, they appreciated [it] when they were dealing with anesthetic feet prior to [MDT]. It's an interesting phenomenon, and probably is worthy of investigation."
He warned that MDT is contraindicated in patients with coagulopathies and in patients with large blood vessels near their wounds.
Diabetic wound healing is hampered by a number of factors, not the least of which is vascular disease. Dr. Eron told the audience that MDT "allowed many of these patients -- three quarters of them -- to be ready for a second phase" of wound treatment, "and in many cases it averts amputation." He compared the median cost of about $500 for MDT to the cost of an amputation, which can be $65,000.
He noted that patients with peripheral vascular disease also have generalized vascular disease, so averting an amputation may allow a patient to live out his or her life with limbs intact. In the study, 5 patients died, usually from heart disease, during follow-up after successful MDT.
These investigators saw, as have others, an apparent antimicrobial effect from the maggot therapy. "It may stimulate defensins, which are part of our innate immune system," Dr. Eron said. "There seems also to be an angiogenesis type of effect because in many cases it converted dry wounds into moist, healthy wounds ... and finally it seemed to stimulate granulation tissue."
51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC): Abstract L-967. Presented on September 18, 2011
Lawrence Eron, MD, infectious disease consultant at Kaiser Moanalua Medical Center and associate professor of medicine at the John A. Burns School of Medicine of the University of Hawaii in Honolulu, stated that, in addition to debriding nonviable tissue, maggots secrete bacteriostatic substances that help eradicate infections in conjunction with antibiotics. He said his talk involved a medical device, "and the device is the maggot."
Dr. Eron said that diabetic limb infections are difficult to treat with antibiotics in part because of vascular insufficiency. Maggot debridement therapy (MDT), using the larvae of the green blowfly (Lucilia sericata), not only removes necrotic tissue without affecting viable tissue but also stimulates the formation of granulation tissue.
Dr. Eron and colleagues used MDT to treat 37 patients with diabetes with complex wounds complicated by diabetic comorbidities. "In some cases, these wounds had been present for as long as 5 years and had failed multiple attempts at treatment," he said. The original wounds were abscesses, infected ulcers, and osteomyelitis with very narrow fistula tracts.
MDT consisted of applying 50 to 100 maggots to a wound, which were covered with nylon mesh fabric (similar to pantyhose) and then removed after 2 days. Clinicians then reapplied more maggots, and the cycles were repeated as necessary (median, 5 cycles; range, 1 - 30 cycles). Maggots were commercially obtained from Monarch Labs at a cost of just under $100 per treatment with 200 maggots.
The researchers defined a successful outcome as elimination of the infection, complete debridement of devitalized tissue, formation of robust granulation tissue, and greater than 50% closure of the wound. "The maggots will not totally heal the wound," Dr. Eron said. "We need other, further methods to heal the wound."
Of the 37 patients, "three quarters, roughly, achieved successful outcomes. The majority had Gram-positive infections. The Gram-positive infections seemed to do better than the Gram-negative anaerobic infections," Dr. Eron reported. The numbers were quite small, however, and a few wounds were culture-negative.
Representative Gram-positive organisms were methicillin-resistant Staphylococcus aureus, methicillin-sensitive S aureus, and group B streptococci. Patients were treated with appropriate, commonly used antibiotics, depending on the infecting organisms.
Failures occurred in patients with severe peripheral vascular disease with narrow fistulae that were not mechanically accessible after they healed after a single treatment in 3 patients with osteomyelitis, with bleeding from wounds (n = 2), or with excessive inflammation around the wound (n = 1). Pain limited treatment for 1 patient, but Dr. Eron said 5 or 6 patients responded well to acetaminophen for discomfort.
"The rest of the patients seemed to acquire, even with their peripheral neuropathy and numbness, some degree of sensation and would feel a creepy, crawly sensation, which they didn't object to," he said. "In fact, they appreciated [it] when they were dealing with anesthetic feet prior to [MDT]. It's an interesting phenomenon, and probably is worthy of investigation."
He warned that MDT is contraindicated in patients with coagulopathies and in patients with large blood vessels near their wounds.
Diabetic wound healing is hampered by a number of factors, not the least of which is vascular disease. Dr. Eron told the audience that MDT "allowed many of these patients -- three quarters of them -- to be ready for a second phase" of wound treatment, "and in many cases it averts amputation." He compared the median cost of about $500 for MDT to the cost of an amputation, which can be $65,000.
He noted that patients with peripheral vascular disease also have generalized vascular disease, so averting an amputation may allow a patient to live out his or her life with limbs intact. In the study, 5 patients died, usually from heart disease, during follow-up after successful MDT.
These investigators saw, as have others, an apparent antimicrobial effect from the maggot therapy. "It may stimulate defensins, which are part of our innate immune system," Dr. Eron said. "There seems also to be an angiogenesis type of effect because in many cases it converted dry wounds into moist, healthy wounds ... and finally it seemed to stimulate granulation tissue."
51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC): Abstract L-967. Presented on September 18, 2011
Friday, October 7, 2011
Hypermobile Flatfoot And Pediatric Obesity: What You Should Know
Given the increasing prevalence of childhood obesity, this author examines the emerging connection with pediatric flatfoot via a thorough review of the current research and discusses the need for further research to support treatment of flatfoot in this population.
Almost daily, you can turn on your TV or open your favorite newspaper and learn about the “national health crisis” that is obesity. There is also a tremendous amount of literature concerning the long-term health pitfalls of morbid obesity and how it can affect the heart, liver, kidney and lymphatic system. Obviously, obesity can also lead to diabetes and a whole host of other health-related issues.
We are also starting to realize that these poor habits begin in our youth and translate to our overall health as adults. This is very apparent if you’ve ever watched The Jamie Oliver Experiment. In this show, the titular young chef travels the United States and tries to revamp cafeterias in public schools to have a menu that is generally healthier, and convince our nation’s youth to modify their lifestyles and help them attain health into adulthood.
As a parent, I am very concerned about my children’s health but does their health translate to their feet as well? Are obese children more prone to a certain foot type? If that is the case, how does that relate to their general health?
A Closer Look At How Researchers Are Identifying Flatfoot In Study Populations
Before starting the discussion of flatfoot studies and their outcomes, I would like to discuss the methodologies of many of these authors with respect to how they determined a flatfoot condition. Many of the studies that I will discuss employed modern methods of determining foot type. We use many of these methods (such as weightbearing radiographic measurements and evaluation of patients in stance and ambulation) in the day-to-day practice of podiatry.
Study authors used these and other more sophisticated methods of determining flatfoot. The other methods included: electronic footprint capture during gait; ultrasonography to measure fat pad thickness; dynamic plantar pressure analysis; and three dimensional laser surface measures. It is important to point out the use of these additional measurement techniques as they lend credence to the outcomes and conclusions of the studies. Without these modalities, one might be tempted to pass off many of the conclusions derived from these studies as “user bias.” However, most of these studies also combined sophisticated measurement techniques with hard data and statistical analysis. This was one the reasons I selected these studies for this review.
Other studies throughout the world’s medical communities have found similar results when studying the relationship with childhood obesity and flatfoot. In doing the research for this article, it became evident that every corner of the world is struggling with this problem of obesity and flatfoot, given the type of research that is occurring with the pediatric population.
What The Research Says About The Effect Of Weight On Pediatric Feet
As we know, infants do not have much of an arch. Even new walkers do not display much of an arch height. Up until approximately the age of 2, when the arch becomes recognizable, it is virtually impossible to assess foot type unless significant pathology is present.
One study attempted to correlate obesity and low arch height in adults.1 The authors found, using footprint-based estimates, that study patients who were obese displayed lower arch heights than their non-obese adult counterparts. Although this study did not focus on the pediatric population, it served as a springboard for others to investigate this topic in obese children as well.
Another study in Australia measured the same basic premise of arch height in obese children.2 The authors found that “obese children had fatter and flatter feet compared to normal weight children.” They did caution, however, that more studies needed to be completed to assess “… the functional and clinical relevance of the increase [sic] … .”2
A similar study out of Spain found similar results when researchers compared the arch height of obese and non-obese children.3 The authors concluded that obese children had lower medial longitudinal arch heights. They did not, however, relate whether lower arch heights were due to a more pronounced fat pad or whether they were due to a more structurally related etiology.
Another study based in Australia also found that obese children had flatter feet.4 Researchers then postulated that this flatter foot morphology could be caused by structural changes in the anatomy of these children’s feet and the morphology can affect function as these children mature into adulthood.
Interestingly, another group of Australian researchers studied the effects of medial midfoot fat pad thickness and how it correlates to plantar pressures in school age children.5 Although the authors did find some correlation between the two factors, they also admitted that this correlation was rather low and more intense study was needed to solidify a more meaningful conclusion.
The last but potentially most telling of the research published in Australia on this topic is a study that took this concept into a more biomechanical realm than the others and examined the kinematics of gait.6 The study patients underwent analyses that measured certain aspects of their gait while they were being filmed walking. What the authors found was that obese children had more “gait asymmetry … a greater stride width … pointing to a slower, more tentative normal speed.” They also found that the obese children were more unstable at a slower walking speed and that they had trouble walking at a faster pace. Additionally, they found that obese children had a more flat-footed and abducted gait at all phases of the gait cycle.
In a study of 835 preschool age children in Austria, the authors found that the most common study group that displayed a flat-footed morphology was the obese male children.7 Researchers went so far to say they observed “a highly significant prevalence of flatfoot” in the overweight child. A study based in Italy found similar results.8 In a study of 243 children between the ages of 8 to 10 years of age, the authors found those who were obese had a higher incidence of moderate and very marked flat-footedness in comparison to their non-obese classmates.
A group in Germany chose a slightly different route to identify the feet of their patients.9 They chose to classify the feet by how they looked and found that overweight children were much more likely to have flat feet or what they called “robust” feet. They did not quantify exactly what “robust” referred to but the description of flat feet was more descriptive of the morphology of the overweight children in any case.
The Taiwanese were so interested in this phenomenon that they generated three separate studies concerning the prevalence of flexible flatfoot in obese school age children. Within these three research articles, researchers evaluated a total of over 4,700 children. This comprises the largest cumulative sample size ever seen with this topic.
The first study was comprised of 1,598 children and its conclusion was that obesity was one of the risk factors of developing this foot type.10 A study concluded one year earlier with a sample size of over 2,000 children showed that male children who were obese were 2.66 times more likely to have a flatfoot morphology than their non-obese classmates.11 The study also noted that female children who were obese were 1.39 times more likely to have this foot morphology than females who were not obese. In addition, researchers noted that obese children of either sex showed this foot morphology between the ages of 7 and 8.
The last of the Taiwanese studies published recently evaluated flatfoot in children between the ages of 5 and 13.12 Researchers found that when combining the children they considered “overweight” and “obese,” there was a very large percentage who had flat feet. Fifty-six percent of children they classified as “obese” had flat feet and 31 percent of those who were “overweight” had flat feet. The one observation with this study that one should note is that the “normal” children had a 27 percent prevalence of obesity. This calls the statistical analysis of the authors’ data into question but we cannot overlook their conclusion.
In Search Of EBM For Flatfoot Treatment In Obese Pediatric Patients
Much of the research shows that to some degree or another, obesity in childhood can lead to flatfoot. Now how do we transfer this knowledge to the care of this pediatric population?
Much of the studies talk about the foot type but few refer to the consequences of this foot type. One journal article that talks about obesity as a potential cause of flatfoot also expresses concern that one should treat this carefully and consider patient adherence and parental involvement in following the treatment plan.13
There are only two papers relating the factors of pediatric obesity, flatfoot and pain. The relationship of the three factors in these articles is not direct but the authors talk of the factors in broader terms as potential explanations for the foot type causing pain. One study discusses pediatric obesity as a potential cause for flatfoot pain via Sever’s disease.14 The other study discusses an increase in symptoms in pediatric patients with rigid flat feet if the patients were in the 95th percentile or higher in weight for their age.15 Once again, there is no literature that offers evidence to suggest a youngster who is obese will eventually become an adult with painful flatfoot.
This is where the vacuum exists. This is our biggest hurdle to overcome to begin the process of justifying the treatment of the pediatric flatfoot. Whether the flatfoot is caused by obesity, connective tissue disorders, severe equinus, compensated metatarsus adductus or the myriad of other potential causes, our next hurdle is to show that left to its own devices, this foot type will cause lasting pain and potential disability if left untreated or supported.
The biggest problem we encounter is how to design a study protocol to test this theory. It is unreasonable to expect that a study protocol would suggest having a treatment group and a control group. In such a hypothetical study, one group would wear orthotics or undergo corrective surgery to reconstruct the foot into a more “neutral” and functional foot type. The other group would just have simple observation. This study would follow the “subjects” over the course of a generation and the results would be calculated regardless of the patient’s lifestyle or job choice. The “subjects” would be followed by a group of practitioners or via a multicenter study over the course of the doctors’ careers and would only be subject to statistical scrutiny as the pediatric patients mature into their adult lives, or beginning in their late teens.
Until a project such as the one described occurs, the evidence basis to justify treatment of flatfoot in obese pediatric patients remains elusive.
Almost daily, you can turn on your TV or open your favorite newspaper and learn about the “national health crisis” that is obesity. There is also a tremendous amount of literature concerning the long-term health pitfalls of morbid obesity and how it can affect the heart, liver, kidney and lymphatic system. Obviously, obesity can also lead to diabetes and a whole host of other health-related issues.
We are also starting to realize that these poor habits begin in our youth and translate to our overall health as adults. This is very apparent if you’ve ever watched The Jamie Oliver Experiment. In this show, the titular young chef travels the United States and tries to revamp cafeterias in public schools to have a menu that is generally healthier, and convince our nation’s youth to modify their lifestyles and help them attain health into adulthood.
As a parent, I am very concerned about my children’s health but does their health translate to their feet as well? Are obese children more prone to a certain foot type? If that is the case, how does that relate to their general health?
A Closer Look At How Researchers Are Identifying Flatfoot In Study Populations
Before starting the discussion of flatfoot studies and their outcomes, I would like to discuss the methodologies of many of these authors with respect to how they determined a flatfoot condition. Many of the studies that I will discuss employed modern methods of determining foot type. We use many of these methods (such as weightbearing radiographic measurements and evaluation of patients in stance and ambulation) in the day-to-day practice of podiatry.
Study authors used these and other more sophisticated methods of determining flatfoot. The other methods included: electronic footprint capture during gait; ultrasonography to measure fat pad thickness; dynamic plantar pressure analysis; and three dimensional laser surface measures. It is important to point out the use of these additional measurement techniques as they lend credence to the outcomes and conclusions of the studies. Without these modalities, one might be tempted to pass off many of the conclusions derived from these studies as “user bias.” However, most of these studies also combined sophisticated measurement techniques with hard data and statistical analysis. This was one the reasons I selected these studies for this review.
Other studies throughout the world’s medical communities have found similar results when studying the relationship with childhood obesity and flatfoot. In doing the research for this article, it became evident that every corner of the world is struggling with this problem of obesity and flatfoot, given the type of research that is occurring with the pediatric population.
What The Research Says About The Effect Of Weight On Pediatric Feet
As we know, infants do not have much of an arch. Even new walkers do not display much of an arch height. Up until approximately the age of 2, when the arch becomes recognizable, it is virtually impossible to assess foot type unless significant pathology is present.
One study attempted to correlate obesity and low arch height in adults.1 The authors found, using footprint-based estimates, that study patients who were obese displayed lower arch heights than their non-obese adult counterparts. Although this study did not focus on the pediatric population, it served as a springboard for others to investigate this topic in obese children as well.
Another study in Australia measured the same basic premise of arch height in obese children.2 The authors found that “obese children had fatter and flatter feet compared to normal weight children.” They did caution, however, that more studies needed to be completed to assess “… the functional and clinical relevance of the increase [sic] … .”2
A similar study out of Spain found similar results when researchers compared the arch height of obese and non-obese children.3 The authors concluded that obese children had lower medial longitudinal arch heights. They did not, however, relate whether lower arch heights were due to a more pronounced fat pad or whether they were due to a more structurally related etiology.
Another study based in Australia also found that obese children had flatter feet.4 Researchers then postulated that this flatter foot morphology could be caused by structural changes in the anatomy of these children’s feet and the morphology can affect function as these children mature into adulthood.
Interestingly, another group of Australian researchers studied the effects of medial midfoot fat pad thickness and how it correlates to plantar pressures in school age children.5 Although the authors did find some correlation between the two factors, they also admitted that this correlation was rather low and more intense study was needed to solidify a more meaningful conclusion.
The last but potentially most telling of the research published in Australia on this topic is a study that took this concept into a more biomechanical realm than the others and examined the kinematics of gait.6 The study patients underwent analyses that measured certain aspects of their gait while they were being filmed walking. What the authors found was that obese children had more “gait asymmetry … a greater stride width … pointing to a slower, more tentative normal speed.” They also found that the obese children were more unstable at a slower walking speed and that they had trouble walking at a faster pace. Additionally, they found that obese children had a more flat-footed and abducted gait at all phases of the gait cycle.
In a study of 835 preschool age children in Austria, the authors found that the most common study group that displayed a flat-footed morphology was the obese male children.7 Researchers went so far to say they observed “a highly significant prevalence of flatfoot” in the overweight child. A study based in Italy found similar results.8 In a study of 243 children between the ages of 8 to 10 years of age, the authors found those who were obese had a higher incidence of moderate and very marked flat-footedness in comparison to their non-obese classmates.
A group in Germany chose a slightly different route to identify the feet of their patients.9 They chose to classify the feet by how they looked and found that overweight children were much more likely to have flat feet or what they called “robust” feet. They did not quantify exactly what “robust” referred to but the description of flat feet was more descriptive of the morphology of the overweight children in any case.
The Taiwanese were so interested in this phenomenon that they generated three separate studies concerning the prevalence of flexible flatfoot in obese school age children. Within these three research articles, researchers evaluated a total of over 4,700 children. This comprises the largest cumulative sample size ever seen with this topic.
The first study was comprised of 1,598 children and its conclusion was that obesity was one of the risk factors of developing this foot type.10 A study concluded one year earlier with a sample size of over 2,000 children showed that male children who were obese were 2.66 times more likely to have a flatfoot morphology than their non-obese classmates.11 The study also noted that female children who were obese were 1.39 times more likely to have this foot morphology than females who were not obese. In addition, researchers noted that obese children of either sex showed this foot morphology between the ages of 7 and 8.
The last of the Taiwanese studies published recently evaluated flatfoot in children between the ages of 5 and 13.12 Researchers found that when combining the children they considered “overweight” and “obese,” there was a very large percentage who had flat feet. Fifty-six percent of children they classified as “obese” had flat feet and 31 percent of those who were “overweight” had flat feet. The one observation with this study that one should note is that the “normal” children had a 27 percent prevalence of obesity. This calls the statistical analysis of the authors’ data into question but we cannot overlook their conclusion.
In Search Of EBM For Flatfoot Treatment In Obese Pediatric Patients
Much of the research shows that to some degree or another, obesity in childhood can lead to flatfoot. Now how do we transfer this knowledge to the care of this pediatric population?
Much of the studies talk about the foot type but few refer to the consequences of this foot type. One journal article that talks about obesity as a potential cause of flatfoot also expresses concern that one should treat this carefully and consider patient adherence and parental involvement in following the treatment plan.13
There are only two papers relating the factors of pediatric obesity, flatfoot and pain. The relationship of the three factors in these articles is not direct but the authors talk of the factors in broader terms as potential explanations for the foot type causing pain. One study discusses pediatric obesity as a potential cause for flatfoot pain via Sever’s disease.14 The other study discusses an increase in symptoms in pediatric patients with rigid flat feet if the patients were in the 95th percentile or higher in weight for their age.15 Once again, there is no literature that offers evidence to suggest a youngster who is obese will eventually become an adult with painful flatfoot.
This is where the vacuum exists. This is our biggest hurdle to overcome to begin the process of justifying the treatment of the pediatric flatfoot. Whether the flatfoot is caused by obesity, connective tissue disorders, severe equinus, compensated metatarsus adductus or the myriad of other potential causes, our next hurdle is to show that left to its own devices, this foot type will cause lasting pain and potential disability if left untreated or supported.
The biggest problem we encounter is how to design a study protocol to test this theory. It is unreasonable to expect that a study protocol would suggest having a treatment group and a control group. In such a hypothetical study, one group would wear orthotics or undergo corrective surgery to reconstruct the foot into a more “neutral” and functional foot type. The other group would just have simple observation. This study would follow the “subjects” over the course of a generation and the results would be calculated regardless of the patient’s lifestyle or job choice. The “subjects” would be followed by a group of practitioners or via a multicenter study over the course of the doctors’ careers and would only be subject to statistical scrutiny as the pediatric patients mature into their adult lives, or beginning in their late teens.
Until a project such as the one described occurs, the evidence basis to justify treatment of flatfoot in obese pediatric patients remains elusive.
Almonds Can Improve Diabetes Control
Two new studies into the potential health benefits of eating almonds have supported evidence that they can help people with type 2 diabetes to maintain their blood glucose and cholesterol levels....
One of the studies, published in the journal, Metabolism, showed that consuming an ounce of almonds straight before eating a high-starch meal brought a 30 per cent reduction in post-meal glucose levels for patients with type 2 diabetes, compared with a 7 per cent reduction for non-diabetics. In addition, after overnight fasting, patients with type 2 diabetes whose meal contained almonds had a lowering of blood sugar levels after their meal.
The effect of regular almond consumption on blood glucose levels for people with type 2 diabetes was also investigated, with the daily consumption of one ounce of almonds over a 12-week period being associated with a 4 per cent reduction in hemoglobin A1c (HbA1c) and the same reduction in body mass index (BMI).
The second study, which was published in Diabetes Care, revealed that nuts such as almonds could help to maintain healthy levels of blood glucose and cholesterol for both men and post-menopausal women who suffer from type 2 diabetes.
Karen Lapsley, chief science officer for the Almond Board of California, commented "Those with diabetes are faced with many challenges with their disease management, which is why we are always energized when new research is published that supports our understanding of almonds' role in helping alleviate some of the difficulties."
Diabetes UK, Diabetes Care, Oct. 2011
One of the studies, published in the journal, Metabolism, showed that consuming an ounce of almonds straight before eating a high-starch meal brought a 30 per cent reduction in post-meal glucose levels for patients with type 2 diabetes, compared with a 7 per cent reduction for non-diabetics. In addition, after overnight fasting, patients with type 2 diabetes whose meal contained almonds had a lowering of blood sugar levels after their meal.
The effect of regular almond consumption on blood glucose levels for people with type 2 diabetes was also investigated, with the daily consumption of one ounce of almonds over a 12-week period being associated with a 4 per cent reduction in hemoglobin A1c (HbA1c) and the same reduction in body mass index (BMI).
The second study, which was published in Diabetes Care, revealed that nuts such as almonds could help to maintain healthy levels of blood glucose and cholesterol for both men and post-menopausal women who suffer from type 2 diabetes.
Karen Lapsley, chief science officer for the Almond Board of California, commented "Those with diabetes are faced with many challenges with their disease management, which is why we are always energized when new research is published that supports our understanding of almonds' role in helping alleviate some of the difficulties."
Diabetes UK, Diabetes Care, Oct. 2011
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