10 October 2010

Can Advanced Therapies Speed Healing Of DFUs?

By Brian McCurdy, Senior Editor

Given that diabetic foot ulcers can result in complications as devastating as amputation, timely healing of such ulcers is critical. A new study in the Archives of Dermatology cites the benefits of advanced biological therapies.

   The study focused on 2,517 patients with diabetic neuropathic foot ulcers who received advanced biological therapy via Apligraf (Organogenesis), becaplermin (Regranex, Systagenix Wound Management) or Procuren (Cytomedix).

   On average, physicians used advanced therapy within 28 days from the patients’ first wound clinic visit, according to the study. The study authors note that wounds treated with engineered skin as the first advanced biological therapy were 31.2 percent more likely to heal than wounds initially treated with topical recombinant growth
factor and 40 percent more likely to heal than those first treated with platelet releasate.

   Paul Kim, DPM, says one can ensure timely healing by optimizing the wound macro-environment (via offloading bony prominences) and micro-environment (via low bacterial counts and optimization of tissue inhibitor of metalloproteinases/matrix metalloproteinases (TIMP/MMP) ratios and adequate microvascular perfusion). He does not believe that every diabetic foot ulcer requires advanced therapies such as bioengineered alternative tissues (BATs) like Apligraf, Dermagraft (Advanced Biohealing), Integra (Integra LifeSciences) or GraftJacket (Wright Medical Technology).

   Dr. Kim does note that a dormant wound that does not demonstrate quantifiable changes in its dimensions over four weeks requires advanced wound healing technologies. Jason Hanft, DPM, concurs, citing Sheehan’s 2003 Diabetes Care study, which found that diabetic foot ulcers that do not decrease by 50 percent after four weeks of treatment have a low probability of healing and a higher chance of complications.

   Such wounds require active treatment products like living skin equivalents and growth factors, according to Dr. Hanft. He also notes that other Diabetes Care studies by Lavery and colleagues in 2006 and Ndip and colleagues in 2010 have emphasized the use of biologically active therapies early in wounds with a higher risk of infection. Dr. Hanft says these wounds include: wounds greater than four weeks old; recurrent diabetic foot ulcers; wounds in patients with renal failure; traumatic wounds; wounds with significant depth; and ischemic wounds.

Are Advanced Therapies Cost Effective?

Although the advanced therapies can be expensive, Dr. Kim says such therapies are “considerably less expensive” than the alternative of amputation. He notes the “staggering costs” associated with amputations caused by untreated or undertreated diabetic foot ulcers. “(Amputations cause) a substantial burden to the healthcare system,” maintains Dr. Kim.
Other costs associated with amputations include lost wages and employability, as well as a decrease in a patient’s overall quality of life, notes Dr. Kim, an Associate Professor at the Midwestern University College of Health Sciences in Glendale, Ariz.

    “I have a friend who is a lower extremity amputee and he always reminds me that ‘We are born with two feet and one is not a spare,’” says Dr. Kim, who emphasizes the need to make every effort to salvage limbs.

   Dr. Hanft agrees that advanced therapies are cost effective.

    “We can significantly reduce costs and save the healthcare system money by rapid use of active therapies and fast wound closure with lower complication rates,” notes Dr. Hanft, the Director of Podiatric Medical Education at Baptist Health in South Miami, Fla.

Study Cites Potential Benefits Of Bariatric Surgery For Patients With Diabetes

By Brian McCurdy, Senior Editor

A new study in the Journal of the American Medical Association finds that bariatric surgery is associated with less usage of diabetes medication and decreased overall healthcare costs.

   The study focused on 2,235 patients with diabetes who underwent bariatric surgery between 2002 and 2005. Among those patients, 1,918 (85.8 percent) were taking at least one diabetes medication three months before surgery with a mean of 4.4 diabetes medications per patient, according to the study. After bariatric surgery, researchers noted the use of any diabetes medication had decreased to 25.3 percent at six months, 19.4 percent at one year and 15.5 percent at two years. As the study notes, follow-up data on 288 patients at three years after surgery revealed that only 13.9 percent continued to take diabetes medication.

   The median cost of the surgical procedure and hospitalization was $29,959, according to the study. Study authors note that in the three years after surgery, total annual healthcare costs per person increased by 9.7 percent in the first year but then decreased by 34.2 percent by the second year after surgery and decreased by 70.5 percent in the third year.

   Patients with type 2 diabetes are more likely to experience good results with bariatric surgery, notes Ryan Fitzgerald, DPM. He points out that such patients normally have more issues with insulin resistance as opposed to a lack of insulin production. He adds that bariatric surgery tends to reverse impaired glucose tolerance in “almost 100 percent” of patients.

   However, Dr. Fitzgerald does warn of potential nutritional issues for patients with diabetes who are considering bariatric surgery. He says patients commonly need post-op augmentation of vitamins to maintain their health. Patients typically have issues with absorbing certain medications, including non-steroidal anti-inflammatory drugs, according to Dr. Fitzgerald, who is in private practice at Hess Orthopaedics and Sports Medicine in Harrisonburg, Va.

   Although bariatric surgery can be successful in eliminating the need for diabetes medications, Dr. Fitzgerald strongly emphasizes the importance of proper patient selection when it comes to referring patients for this procedure.

    “There is certainly the potential for bariatric surgery to be viewed as an easy out instead of more far reaching lifestyle modifications,” he says. “However, the reality is that these procedures are not minor surgeries and carry a significant risk as well as requiring fairly specific post-procedure protocols.”

Is Early Weightbearing Feasible After Lapidus Arthodesis?

By Brian McCurdy, Senior Editor

Although patients reportedly should remain non-weightbearing for six weeks after Lapidus arthrodesis, a recent study in the Journal of Foot and Ankle Surgeons finds that protected weightbearing can get patients back on their feet quicker.

   The study was a multicenter retrospective review of 80 feet in 76 patients who had a Lapidus arthrodesis and a similar fixation technique. The study authors allowed all patients protected weightbearing in a Jones splint or short leg removable immobilizing brace, starting about two weeks after surgery.

   The study authors reported that all 80 feet proceeded to successful union with a mean time to union of 44.5 days. The study notes no broken hardware or complications requiring surgical revision. In addition, patients achieved statistically significant improvements in the first intermetatarsal, hallux abductus and lateral metatarsal angles, and the study adds that surgeons did not encounter any incidence of pathological first ray elevatus.

   The best predictor for a good result with early weightbearing after Lapidus arthrodesis is achieving solid stable internal fixation, according to lead study author Neal Blitz, DPM. He notes a strong fixation construct is necessary to keep the fusion site stable as the patient applies weight and bony consolidation occurs. Patients should understand that progressing their weightbearing is a process dependent on their ability to tolerate placing weight on the foot, according to Dr. Blitz, the Chief of Foot Surgery in the Department of Orthopaedic Surgery at the Bronx-Lebanon Hospital Center in Bronx, N.Y.

   Early weightbearing after Lapidus arthrodesis is contraindicated in patients with significant peripheral neuropathy, morbid obesity and osteoporosis, notes Dr. Blitz, a Fellow of the American College of Foot and Ankle Surgeons. He says one may utilize the protocol cautiously and selectively in smokers. However, Dr. Blitz maintains that surgeons should encourage cessation of smoking since there is an increased nonunion risk.

In Brief

Pedinol Pharmacal Inc. has donated $810 to the American Podiatric Medical Association (APMA) Educational Foundation in recognition of podiatrists who participated in a marketing survey in July. Pedinol donated $10 to the APMA Educational Foundation for every podiatrist who completed an online marketing survey, according to the company.

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