Transitioning To Advanced Therapies For DFUs: Are Four Weeks And 50 Percent The Magic Numbers?

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What One Study Reveals About A Bioengineered Skin Substitute And The Rate Of Healing Of Diabetic Foot Ulcers

In a prospective, randomized, multicenter study, Veves and colleagues analyzed 208 patients with diabetes who had full-thickness neuropathic ulcers, and observed the healing rates of diabetic neuropathic ulcers that were treated with Apligraf (Organogenesis) versus diabetic neuropathic ulcers treated with saline-moistened gauze.10 At baseline, the two groups were similar in regard to demographics, the type and duration of diabetes, and ulcer size and duration. The Apligraf group was comprised of 112 patients and there were 96 patients in the control group, which utilized saline-moistened gauze as treatment. Both groups received periodic debridement and offloading in addition to the respective treatment for their group.

The researchers analyzed 162 patients at the end of the study. The rate of healing was higher among those who had Apligraf applied every week than those who received saline moistened gauze. At the 12-week follow-up visit, 63 (56 percent) Apligraf-treated patients were completely healed in comparison to 36 patients (38 percent) treated with saline-moistened gauze. The average time to complete closure was 65 days for Apligraf, significantly lower than the 90 days researchers observed in the saline-moistened gauze group.

The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis (3 percent in the Apligraf group versus 10 percent in the control group) and lower-limb amputations (6 percent versus 16 percent), both of which were less frequent in the Apligraf group. The study also noted the improvement in maceration, exudates and eschar in the Apligraf group from week 0 to week 12. Physicians should consider Apligraf for the management of diabetic foot ulcers that are resistant to the currently available standard of care.

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Author(s): 
Chanel Houston, DPM, Samirah Mohammed, DPM, and Peter A. Blume, DPM, FACFAS

   Infection also impedes wound healing and is usually a consequence, rather than a cause, of ulceration. Infection allows the entry of microorganisms and subsequent multiplication of these microorganisms. In view of the fact that a diabetic foot infection has the potential to threaten the limb, appropriate diagnosis and therapy are urgently required. Having a way to evaluate healing potential for a particular therapy may help physicians change to more aggressive therapies earlier in the treatment process in efforts to drastically lower infection risks and prevent lower extremity amputations.

   While the understanding of the etiology of diabetic foot ulcers continues to progress, treatment therapies are advancing and amputation rates are declining.

Essential Diagnostic Considerations

Patients with diabetes who present with ulcerations on the foot usually have arterial insufficiency as evidenced by weakly or non-palpable pedal pulses, ischemic changes in the setting of gangrene, or skin atrophy.2 The ulcerations are typically located on the plantar aspect of the foot in weightbearing areas such as plantar metatarsal head regions. One may also find ulcerations at the distal aspect of pedal digits. This is due to the effects of motor neuropathy leading to retrograde buckling, which results in hammertoe formation, creating callosities and subsequent ulceration. Sensory neuropathy in the patient with diabetes can be characterized by a decreased or absent light touch sensation when one tests specific pedal areas with a 10-gram Semmes-Weinstein monofilament.2

   Osteomyelitis is always an underlying concern in the face of any ulceration, especially ulcerations that are chronic in nature. Radiographs, magnetic resonance imaging and triphasic bone scans are excellent diagnostic modalities, and can help tailor treatment protocols. Clinicians may also obtain wound cultures from infected wounds in efforts to optimize appropriate antibiotic therapy.2

   Vascular insufficiency is another consideration when dealing with diabetic ulcers.2,3 Various vascular studies can help assess the hemodynamics of vascular insufficiency. Unfortunately, one vascular study that is not very beneficial to the patient with diabetes is the ankle-brachial pressure index (ABI), which is often falsely elevated since patients with diabetes have calcified vessels that will not compress. Pulse volume recordings (PVRs) may prove more accurate in determining the significance of arterial disease in patients with diabetes than an ABI.2

   Magnetic resonance angiography is another useful tool for imaging atherosclerotic disease. Healing cannot occur in the presence of hypoxia, which can still persist even post-revascularization.1 Measuring the transcutaneous oxygen tension (TcPO2) proves helpful in these cases since a value above 30 mmHg suggests a high healing potential.2

A Pertinent Overview Of Treatment Options For Diabetic Foot Ulcerations

The cost to manage foot disorders is estimated at several billion dollars annually.4,5 Researchers have estimated that in the United States, 4.6 to 13.7 billion dollars are spent every year for the treatment of diabetic peripheral neuropathy and its complications. This dollar amount accounts for approximately 27 percent of the direct medical costs of diabetes.6 Successful clinical management of diabetic foot ulcers not only has the potential to reduce the cost of caring for these patients, it can improve the patient’s quality of life by reducing comorbidities.

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