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

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 Carlo Caravaggi , MD 1 , Roberto De Giglio , MD 1 , Chiara Pritelli , MD 1 , Manuela Sommaria , MD 1 , Sergio Dalla Noce , MD 1 , Ezio Faglia , MD 2 , Manuela Mantero , MD 2 , Giacomo Clerici , MD 3 , Pietro Fratino , MD 3 , Luca Dalla Paola , MD 4 , Giulio Mariani , MD 5 , Roberto Mingardi , MD 6 and Alberto Morabito , PHD 7 1 Centre for the Study and Treatment of Diabetic Foot Pathology, Ospedale di Abbiategrasso, Milan, Italy 2 Policlinico Multimedica, Sesto San Giovanni, Milan, Italy 3 Centro per la Prevenzione e la Cura del Piede Diabetico-Fondazione Maugeri, Pavia, Italy 4 Casa di Cura Villa Berica, Vicenza, Italy 5 Divisione Medicina, Ospedale San Carlo, Milan, Italy 6 Ospedale San Bortolo, Vicenza, Italy 7 Institute of Medical Statistics and Biometry, University of Milan, Milan, Italy Address correspondence and reprint requests to Dr.Carlo Caravaggi, Centre for the Study and Treatment of Diabetic Foot Pathology, Ospedale di Abbiategrasso (MI), Piazza Mussi, 1, 20081 Abbiategrasso (MI), Italy. E-mail: carlo.caravaggi{at}fastwebnet.it Abstract 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 fo