Open AccessA prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers
Author(s) -
Zelen Charles M,
Serena Thomas E,
Denoziere Guilhem,
Fetterolf Donald E
Publication year - 2013
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/iwj.12097
Subject(s) - medicine , diabetic foot , prospective cohort study , foot (prosody) , surgery , diabetes mellitus , endocrinology , linguistics , philosophy
Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts ( EpiFix ®, MiMedx , Kennesaw, GA ) versus standard of care. An IRB ‐approved, prospective, randomised, single‐centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4‐week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix . Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. In the standard care group ( n = 12) and the EpiFix group ( n = 13) wounds reduced in size by a mean of 32·0% ± 47·3% versus 97·1% ± 7·0% ( P < 0·001) after 4 weeks, whereas at 6 weeks wounds were reduced by −1·8% ± 70·3% versus 98·4% ± 5·8% ( P < 0·001), standard care versus EpiFix , respectively. After 4 and 6 weeks of treatment the overall healing rate with application of EpiFix was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds ( P < 0·001), respectively. Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing.