Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study.
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.
Advanced Clinical Research, LLC, Castro Valley, CA, USA.
Alexander
A
Reyzelman
Ryan T
RT
Crews
John C
JC
Moore
Lily
L
Moore
Jagpreet S
JS
Mukker
Stephen
S
Offutt
Arthur
A
Tallis
William B
WB
Turner
Dean
D
Vayser
Christopher
C
Winters
David G
DG
Armstrong
D000328:Adult; D000368:Aged; D017719:Diabetic Foot / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D019651:Plastic Surgery Procedures / Q000379:methods*; D013997:Time Factors; D023822:Tissue Engineering / Q000379:methods*; D014945:Wound Healing / Q000502:physiology