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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]
Appears in following Topics:
Diabetic Foot Ulcer - Treatment
Cellular and/or Tissue Based Products