Summary:
This study, conducted by Zelen CM, Serena TE, Denoziere G, and Fetterolf DE, explores the effectiveness of a dehydrated human amniotic membrane allograft (EpiFix) in treating diabetic foot ulcers, a common and challenging complication in diabetic patients. The randomized controlled trial compared the healing characteristics of foot ulcers treated with EpiFix versus standard care alone over a 6-week period.
Objective:
To evaluate the healing efficacy of EpiFix, a dehydrated human amniotic membrane allograft, when used in combination with standard care for diabetic foot ulcers.
Study Design:
The trial was a prospective, stratified, randomized, parallel group, non-blinded, single-center study. Twenty-five patients with type 1 or type 2 diabetes and a diabetic foot ulcer participated. Patients were randomized to either receive standard care (n=12) or standard care plus EpiFix (n=13). Primary outcomes included reduction of wound size and complete healing at 4 and 6 weeks.
Results:
The group treated with EpiFix experienced significantly greater wound size reduction and higher complete healing rates compared to the standard care group. At 6 weeks, 92% of the EpiFix group had fully healed ulcers, while only 8% of the standard care group reached complete healing. This demonstrated the substantial efficacy of EpiFix in promoting wound healing for diabetic foot ulcers.
Conclusion:
EpiFix significantly improves healing outcomes for diabetic foot ulcers compared to standard care alone, indicating its potential value in clinical practice. However, the study’s small sample size and lack of comparison with other advanced therapies suggest the need for further research.
For more details, refer to the original article: Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):502-507.