HYAFF 11–Based Autologous Dermal and Epidermal Grafts in the Treatment of Noninfected Diabetic Plantar and Dorsal Foot Ulcers

OBJECTIVE — To evaluate the clinical efficacy and safety of HYAFF 11–based autologous dermal and epidermal grafts in the management of diabetic foot ulcers. RESEARCH DESIGN AND METHODS — A total of 79 patients with diabetic dorsal (n 37) or plantar (n 42) ulcers were randomized to either the control group with non-adherent paraffin gauze (n 36) or the treatment group with autologous tissue-engineered grafts (n 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events. RESULTS — Complete ulcer healing was achieved in 65.3 % of the treatment group and 49.6 % of the control group (P 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50 % in the treatment and control groups, respectively. Dorsal foot ulcer healing was signif-icantly different, with 67 % in the treatment group and 31 % in the control group (P 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P 0.037). Adverse events wer