Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: A prospective, randomised, multicentre study

Alexander Reyzelman, Ryan T. Crews, John C. Moore, Lily Moore, Jagpreet S. Mukker, Stephen Offutt, Arthur Tallis, William B. Turner, Dean Vayser, Christopher Winters, David G. Armstrong

Research output: Contribution to journalArticle

102 Scopus citations

Abstract

This 12-week, prospective, randomised, controlled multi-centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix (AM) (study group) and standard of care (control group) therapies. Eighty-six patients were randomised into study (47 patients) and control (39 patients) groups. No significant differences in demographics or pre-treatment ulcer data were calculated. Complete healing and mean healing time were 69·6% and 5·7 weeks, respectively, for the study group and 46·2% and 6·8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant (P = 0·0289), with odds of healing in the study group 2·7 times higher than in the control group. Kaplan-Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate (P = 0·015) for the control group (53·9%) compared with the study group (30·4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate (P = 0·0194), a statistically significant difference in non healing rate between groups was calculated (P = 0·0233), with odds of healing 2·0 times higher in the study versus control group. This study supports the use of single-application AM therapy as an effective treatment of diabetic, neuropathic ulcers.

Original languageEnglish (US)
Pages (from-to)196-208
Number of pages13
JournalInternational Wound Journal
Volume6
Issue number3
DOIs
StatePublished - Jun 1 2009

Keywords

  • Acellular regenerative tissue matrix
  • Bioengineered matrix
  • Diabetes mellitus
  • Foot ulcer
  • Wound

ASJC Scopus subject areas

  • Surgery
  • Dermatology

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