Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers - A prospective randomized multicenter clinical trial

OBJECTIVE- We assessed in a randomized prospective trial the effectiveness of Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers. RESEARCH DESIGN AND METHODS- In 24 centers in the U.S., 208 patients were r andomly assigned to ulcer treatment either with Graftskin (112 patients) or saline-moistened gauze (96 patients, control group). Standard state-of-the -art adjunctive therapy which included extensive surgical debridement and a dequate foot off-loading, was provided in both groups. Graftskin was applie d at the beginning of the study and weekly thereafter for a maximum of 4 we eks (maximum of five applications) or earlier if complete healing occurred. The major outcome of complete wound healing was assessed by intention to t reat at the 12-week follow-up visit. RESULTS- At the 12-week follow-up visit, 63 (56%) Graftskin-treated patient s achieved complete wound healing compared with 36 (38%) in the control gro up (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 da ys for Graftskin, significantly lower than the 90 days observed in the cont rol group (P = 0.0026). The odds ratio for complete healing for a Graftskin -treated ulcer compared with a control-treated ulcer was 2.14 (95% CI 1.23- 3.74). The rate of adverse reactions was similar bem een the two groups wit h the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Graftskin group. CONCLUSIONS- Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently availabl e treatment and is not associated with any significant side effects. Grafts kin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available standard of care.