Résumé
PURPOSE: To evaluate clinical efficacy and safety of hyaluronic acid based autologous dermal fibroblasts (Hyalograft 3D) in the treatment of diabetic foot ulcers. METHODS: A total of 28 patients with diabetic ulcers were randomized to either the control group with nonadherent foam dressings(n=14) or the treatment group with autologous tissue-engineered grafts(n=14). Weekly assessment contained vital sign checks, ulcer size measurements, and wound photos. In the 12th week, percentages of complete wound healing and mean healing times were compared. Safety was also monitored by adverse events. RESULTS: Complete wound healing was achieved in 84.6% of the treatment group and 23.1% of the control group(p<0.005). The mean times of closures for the treatment versus control groups were 6.1 weeks and 10.9 weeks, respectively. No adverse events related to the study treatment occurred. CONCLUSION: The use of hyaluronic acid based autologous fibroblast grafts was found to be a safe and effective treatment for diabetic foot ulcers.