Reyzelman A, Crews RT, Moore JC, Moore L, Mukker JS, Offutt S, Tallis A, Turner WB, Vayser D, Winters C, Armstrong DG, et al.
International wound journal. Date of publication 2009 Jun 1;volume 6(3):196-208.
1. Int Wound J. 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.
Reyzelman A(1), Crews RT, Moore JC, Moore L, Mukker JS, Offutt S, Tallis A,
Turner WB, Vayser D, Winters C, Armstrong DG.
Author information:
(1)Advanced Clinical Research, LLC, Castro Valley, CA, USA.
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.
DOI: 10.1111/j.1742-481X.2009.00585.x
PMID: 19368581 [Indexed for MEDLINE]
