Summary:
This randomized controlled trial, conducted by Zelen CM, Serena TE, Denoziere G, and Fetterolf DE, aimed to assess the effectiveness of dehydrated human amniotic membrane allografts (EpiFix) in treating diabetic foot ulcers compared to standard care. The study involved 25 patients with chronic diabetic foot ulcers, split into two groups: one receiving EpiFix with standard care and the other receiving only standard care. The results showed that the EpiFix group had significantly higher rates of wound healing. At 6 weeks, 92% of patients in the EpiFix group achieved complete wound healing compared to only 8% in the standard care group. This indicates the potential of amniotic membrane allografts as an effective treatment for diabetic foot ulcers.
Objective:
To assess the efficacy of EpiFix, a dehydrated human amniotic membrane allograft, in promoting wound healing in chronic diabetic foot ulcers when used alongside standard care, compared to standard care alone.
Study Design:
The trial was a prospective, randomized, controlled, parallel-group study involving 25 patients with diabetic foot ulcers. Patients were randomized into two groups: one receiving EpiFix along with standard care and the other receiving standard care alone. The study spanned over 6 weeks, with the primary outcome being the rate of complete wound healing.
Results:
At the end of 6 weeks, 92% of the patients in the EpiFix group achieved complete wound healing, compared to only 8% in the standard care group. The EpiFix group also showed a significant reduction in wound size and faster healing rates at both 4 and 6 weeks.
Conclusion:
The study demonstrated that the use of EpiFix significantly improved the healing outcomes of chronic diabetic foot ulcers compared to standard care alone, suggesting its efficacy as a promising treatment for diabetic ulcers.
For more details, refer to the original article:
Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):502-507.