Evaluation of a human skin equivalent for the treatment of diabetic foot ulcers in a prospective, randomized, clinical trial

The primary objective of this trial was to assess the ability of a human sk in equivalent* to improve the median time to wound closure and the wound cl osure rate in nonischemic, non-infected diabetic foot ulcers. This was a pr ospective, randomized, placebo-controlled study. Patients in the skin equiv alent group received treatment material once a week for a maximum of four w eeks (five applications). Skin equivalent treatment was compared to a contr ol treatment consisting of woven gauze kept moist by saline. Proper wound c are, including extensive debridement and weight offloading, was provided to all participants. Sixteen patients were treated with a skin equivalent app lication once a week for a maximum of four weeks and were compared to 17 co ntrol patients matched for age, sex, diabetes duration, ulcer size, ABI, Hb A1c, and ulcer duration. The Kaplan-Meier median time to complete closure w as 38.5 days for skin equivalent, significantly lower than the 91 days obse rved in the control group (p<0.01). Complete wound closure was achieved in 12 (75 percent) skin equivalent-treated patients compared to seven (41 perc ent) control-treated patients (p<0.05 Chi-square test). The results demonst rate that weekly application of the skin equivalent, a bilayered living hum an skin analog, onto diabetic foot ulcers for a maximum of four weeks resul ts in a higher healing rate when compared to currently available state-of-t he-art treatment. Treatment with the skin equivalent was not associated wit h any significant side effects and may prove to be a very useful adjunct fo r the management of chronic diabetic foot ulcers, which are resistant to th e currently available standard care.