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

94 Citations (Scopus)

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 2009

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Acellular Dermis
Diabetic Foot
Multicenter Studies
Ulcer
Control Groups
Wounds and Injuries
Kaplan-Meier Estimate
Standard of Care
Group Psychotherapy
Therapeutics
Survival Rate
Demography

Keywords

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

ASJC Scopus subject areas

  • Surgery
  • Dermatology

Cite this

Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers : A prospective, randomised, multicentre study. / Reyzelman, Alexander; Crews, Ryan T.; Moore, John C.; Moore, Lily; Mukker, Jagpreet S.; Offutt, Stephen; Tallis, Arthur; Turner, William B.; Vayser, Dean; Winters, Christopher; Armstrong, David G.

In: International Wound Journal, Vol. 6, No. 3, 06.2009, p. 196-208.

Research output: Contribution to journalArticle

Reyzelman, Alexander ; Crews, Ryan T. ; Moore, John C. ; Moore, Lily ; Mukker, Jagpreet S. ; Offutt, Stephen ; Tallis, Arthur ; Turner, William B. ; Vayser, Dean ; Winters, Christopher ; Armstrong, David G. / Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers : A prospective, randomised, multicentre study. In: International Wound Journal. 2009 ; Vol. 6, No. 3. pp. 196-208.
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