TY - JOUR
T1 - Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers
T2 - A prospective, randomised, multicentre study
AU - Reyzelman, Alexander
AU - Crews, Ryan T.
AU - Moore, John C.
AU - Moore, Lily
AU - Mukker, Jagpreet S.
AU - Offutt, Stephen
AU - Tallis, Arthur
AU - Turner, William B.
AU - Vayser, Dean
AU - Winters, Christopher
AU - Armstrong, David G.
PY - 2009/6
Y1 - 2009/6
N2 - 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.
AB - 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.
KW - Acellular regenerative tissue matrix
KW - Bioengineered matrix
KW - Diabetes mellitus
KW - Foot ulcer
KW - Wound
UR - http://www.scopus.com/inward/record.url?scp=67650745184&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67650745184&partnerID=8YFLogxK
U2 - 10.1111/j.1742-481X.2009.00585.x
DO - 10.1111/j.1742-481X.2009.00585.x
M3 - Article
C2 - 19368581
AN - SCOPUS:67650745184
SN - 1742-4801
VL - 6
SP - 196
EP - 208
JO - International Wound Journal
JF - International Wound Journal
IS - 3
ER -