Abstract

This study compared the efficacy and safety of Apligraf (Organogenesis, Inc., Canton, MA) in combination with standard therapy versus standard therapy alone in the treatment of neuropathic diabetic foot ulcers. Efficacy was assessed by time to complete wound healing (by 12 weeks) and incidence of complete wound closure (at 12 weeks). This was an international multi-center, randomized, controlled study. Patients were eligible for entry into the study if the following criteria were met: type 1 or type 2 diabetes mellitus, age 18 to 80 years, adequate glycemic control, and the presence of a full-thickness neuropathic ulcer for at least 2 weeks prior to the initial screening visit. Following the 2-week screening period, the 2 treatment groups received standard ulcer care consistent with international treatment guidelines that comprised sharp debridement, saline-moistened dressings, and a non—weight bearing regimen. There were 106 subjects screened for enrollment, 82 randomized to the treatment groups, and 72 treated (33 Apligraf subjects and 39 standard therapy subjects) before the study was terminated. Kaplan—Meier curves indicated a trend for shorter time to complete wound healing in the Apligraf group compared with the standard therapy group (p = .059; log-rank test). The median time to healing was 84 days in the Apligraf group, whereas no median time to healing could be determined for the standard therapy group because <50% of the standard therapy subjects healed. By 12 weeks, 51.5% (17/33) Apligraf subjects had achieved complete wound closure compared with 26.3% (10/38) of standard therapy subjects (p = .049; Fisher's exact test). Even though the study was halted prematurely, this study suggested that the use of Apligraf resulted in a higher incidence of wound closure by 12 weeks.