Int Wound J · 2016
A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers
Zelen, C.M., Orgill, D.P., Serena, T., Galiano, R., Carter, M.J., DiDomenico, L.A., Keller, J., Kaufman, J., & Li, W.W.
International Wound Journal, 2016
In brief
In this randomized controlled trial at five US outpatient wound centers (NCT02331147), 40 patients with non-healing diabetic foot ulcers received standard care alone or standard care plus a weekly human reticular acellular dermal matrix graft for up to 12 weeks. At the 6-week primary endpoint, 65% (13/20) of graft-treated ulcers had healed compared with 5% (1/20) with standard care alone, a statistically significant difference (P = 0.00028); at 12 weeks the rates were 80% and 20% (P = 0.00036), but ten standard care patients and one graft patient had been exited at 6 weeks per protocol for less than 50% area reduction, which the authors note causes extensive right censoring at 12 weeks. No adverse events were judged related to the graft; patients and investigators were not blinded (healing was reviewed by blinded adjudicators), and the trial was funded by the graft's supplier, the Musculoskeletal Transplant Foundation.
Co-authored by Dr. Thomas Serena, SerenaGroup's founder.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
Acellular dermal matrices can successfully heal wounds. This study’s goal was to compare clinical outcomes of a novel, open-structure human reticular acellular dermis matrix (HR-ADM) to facilitate wound closure in non-healing diabetic foot ulcers (DFUs) versus DFUs treated with standard of care (SOC). Following a 2-week screening period in which DFUs were treated with offloading and moist wound care, patients were randomised to either SOC alone or HR-ADM plus SOC applied weekly for up to 12 weeks. At 6 weeks, the primary outcome time, 65% of the HR-ADM-treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At 12 weeks, the proportions of DFUs healed were 80% and 20%, respectively. Mean time to heal within 12 weeks was 40 days for the HR-ADM group compared with 77 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any adverse events related to the graft. Mean and median graft costs to closure per healed wound in the HR-ADM group were $1475 and $963, respectively. Weekly application of HR-ADM is an effective intervention for promoting closure of non-healing DFUs.
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