Diabetic Foot Ulcer Study

Diabetic foot is one of the most significant and devastating complications of diabetes, defined as a foot affected by ulceration that is associated with neuropathy and/or peripheral arterial disease of the lower limb. It is estimated that about 5% of all patients with diabetes present with a history of foot ulceration, while the lifetime risk of diabetic patients developing this complication is 15%.

The majority (60–80%) of foot ulcers will heal, while 10–15% of them will remain active, and 5–24% of them will finally lead to limb amputation within a period of 6–18 months after the first evaluation. In the view of reducing this morbidity, researchers at the University of Texas conducted a double-blinded sham-controlled clinical trial which was published in the Journal of Diabetic Care.

The study was done to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with a standard of care (SOC) alone.

The double-blind sham-controlled clinical trial was a multicenter study of patients with type 1 or type 2 diabetes from 17 diabetic foot centers across the United States, United Kingdom, France, Germany, and Luxembourg. All patients received optimal standard of care and were randomly assigned to receive active TWO2 therapy or sham control treatment. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks.

• 37 patients were randomly assigned to standard of care and sham therapy (mean age, 61.9±9.5 years; 84% men) and 36 to the standard of care and active TWO2 therapy (mean age, 64.6±10.3 years; 89% men).
• Of these, 3 patients in the active therapy group and 4 patients in the control group were lost to follow-up.

At 12 weeks, the active TWO2 therapy was superior to sham therapy, as complete healing was evident in 15 wounds (41.7%) compared with 5 wounds (13.5%), respectively. The study had several limitations, including its small sample size and focus on patients with more difficult wounds to heal.

"This robust double-blinded, sham-controlled trial provides evidence to support use of this adjunctive cyclical pressurized [topical oxygen therapy] for chronic [diabetic foot ulcers]," concluded the researchers.

For further reading, click on the following link: https://doi.org/10.2337/dc19-0476