HYAFF 11-based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers: a prospective, multicenter, controlled, randomized clinical trial.

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 nonadherent 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 significantly 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 were equally distributed between the two groups, and none were related to the treatments. CONCLUSIONS: The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied.

Intramedullary compressive nail fixation for the treatment of severe Charcot deformity of the ankle and rear foot.

Involvement of the ankle joint in Charcot osteoarthropathy may be associated with severe instability and fracture or collapse of the talus. Recalcitrant ulceration may result over the lateral malleolus, increasing the risk of major amputation. This study evaluated ankle arthrodesis with a compressive intramedullary nail in 14 patients with diabetes affected by Charcot of the ankle. The mean patient age was 58 +/- 12 years, and the mean duration of diabetes was 17 +/- 5 years. Transcutaneous oxygen pressures were > or = 50 mm Hg in all patients, indicating a good distal blood supply. A below-knee amputation had previously been suggested because of severe ankle joint instability. None of the patients were able to walk without a brace. Four patients had an ulceration that had healed before the index procedure. All procedures were performed in the quiescent phase of the disease. After a mean follow-up of 18 +/- 4 months, 10 patients (71.4%) achieved a solid arthrodesis, returning to walking with protective shoes. Three patients (21.4%) developed breakage of the calcaneus screws, necessitating removal of the screws in 2 cases and removal of the entire nail in 2 cases. These 3 patients went on to fibrous union that allowed walking with a brace. One patient (7.2%) required a below-knee amputation because of postoperative osteomyelitis of the distal tibia. The data from our study demonstrate a high rate of limb salvage (92.8%), suggesting that this device is safe and effective in the treatment of Charcot arthropathy of the ankle.