The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial.
OBJECTIVE
To determine if a human fibroblast-derived dermal substitute could promote the healing of diabetic foot ulcers.


METHODS
A randomized, controlled, multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks. Patients were randomized to either the Dermagraft treatment group or control (conventional therapy). Except for the application of Dermagraft, treatment of study ulcers was identical for patients in both groups. All patients received pressure-reducing footwear and were allowed to be ambulatory during the study.


RESULTS
The results demonstrated that patients with chronic diabetic foot ulcers of >6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone. With regard to complete wound closure by week 12, 30.0% (39 of 130) of Dermagraft patients healed compared with 18.3% (21 of 115) of control patients (P = 0.023). The overall incidence of adverse events was similar for both the Dermagraft and control groups, but the Dermagraft group experienced significantly fewer ulcer-related adverse events.


CONCLUSIONS
The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers.
Marston
William A
WA
University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7212, USA. sky@med.unc.edu
Hanft
Jason
J
Norwood
Paul
P
Pollak
Richard
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015925:Cryopreservation; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D005347:Fibroblasts / Q000166:cytology; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D015203:Reproducibility of Results; D012449:Safety; D012775:Shoes; D017768:Skin, Artificial / Q000009:adverse effects / Q000592:standards*