Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients

Lawrence A. DiDomenico, Dennis P. Orgill, Robert D. Galiano, Thomas E. Serena, Marissa J. Carter, Jarrod P. Kaufman, Nathan J. Young, Allen M. Jacobs, Charles M. Zelen*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non-healing DFUs. After a 2-week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA-treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA- treated group compared with SOC, 37 days vs 67 days in the SOC group (P =.000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.

Original languageEnglish (US)
Pages (from-to)950-957
Number of pages8
JournalInternational Wound Journal
Volume15
Issue number6
DOIs
StatePublished - Dec 2018

Keywords

  • amnion/chorion graft
  • complete wound healing
  • diabetic foot ulcer
  • randomised controlled trial
  • time to heal

ASJC Scopus subject areas

  • Surgery
  • Dermatology

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