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Randomized Controlled Trial
. 2009 Jun;6(3):196-208.
doi: 10.1111/j.1742-481X.2009.00585.x. Epub 2009 Apr 2.

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  1 , 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
Affiliations
Randomized Controlled Trial

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 et al. Int Wound J. 2009 Jun.

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.

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Figures

Figure 1
Figure 1
Flow chart of patient accounting for clinical trial.
Figure 2
Figure 2
Comparison of index ulcer location between treatment groups.
Figure 3
Figure 3
Kaplan–Meier survivorship analysis for time to complete healing by treatment.
Figure 4
Figure 4
Healing proportion curve by treatment.
See this image and copyright information in PMC

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