An evaluation of healing metrics associated with commonly used advanced wound care products for the treatment of chronic diabetic foot ulcers.

Purpose: As rates of diabetes escalate worldwide, diabetic foot ulcers are an increasingly significant public health problem. Advanced wound therapies that promote rapid and complete healing, thus reducing the risk for infection and amputation, can substantially improve quality of life while decreasing financial burdens to the individual and health care system. Our purpose is to compare standardized healing metrics in patients with diabetic foot ulcers treated with three widely used advanced wound-healing products. Design: Retrospective analysis of data collected and reported in published randomized controlled trials, physician product prescribing information, and premarket approval summary documents from the U.S. Food and Drug Administration. Methodology: Rates of complete wound closure within 12 weeks, time to healing, number of graft applications to wound closure, durability of healed wounds, and safety were examined for patients with diabetic ulcers treated with Apligraf, Dermagraft, or EpiFix. Results: Complete wound closure within 12 weeks of treatment initiation occurred in 56%, 30%, and 92% of Apligraf-, Dermagraft-, and EpiFix-treated ulcers, respectively. EpiFix-treated ulcers had the shortest time to healing (median 14 days) and least amount of graft material used (14 cm2) versus comparative products. Rate of ulcer recurrence was 5.9% for Apligraf (after 6 months), 18.8% for Dermagraft (after 8 months), and 5.6% for EpiFix (after 9–12 months). Conclusion: Although prospective comparative effectiveness trials are needed, the differences recorded suggest EpiFix results in the most rapid improvement and resolution of diabetic foot ulcers.