Zelen CM, Serena TE, Denoziere G, Fetterolf DE, et al.
International wound journal. Date of publication 2013 Oct 1;volume 10(5):502-7.
1. Int Wound J. 2013 Oct;10(5):502-7. doi: 10.1111/iwj.12097. Epub 2013 Jun 7.
A prospective randomised comparative parallel study of amniotic membrane wound
graft in the management of diabetic foot ulcers.
Zelen CM(1), Serena TE, Denoziere G, Fetterolf DE.
Author information:
(1)Department of Clinical Research, Professional Education and Research
Institute, Inc., Roanoke, VA, USA.
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.
©2013 The Authors. International Wound Journal published by John Wiley & Sons Ltd
and Medicalhelplines.com Inc.
DOI: 10.1111/iwj.12097
PMCID: PMC4232235
PMID: 23742102 [Indexed for MEDLINE]
