Marston WA, Hanft J, Norwood P, Pollak R, Dermagraft Diabetic Foot Ulcer Study Group., et al.
Diabetes care. Date of publication 2003 Jun 1;volume 26(6):1701-5.
1. Diabetes Care. 2003 Jun;26(6):1701-5.
The efficacy and safety of Dermagraft in improving the healing of chronic
diabetic foot ulcers: results of a prospective randomized trial.
Marston WA(1), Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study
Group.
Author information:
(1)University of North Carolina School of Medicine, Chapel Hill, North Carolina
27599-7212, USA. sky@med.unc.edu
OBJECTIVE: To determine if a human fibroblast-derived dermal substitute could
promote the healing of diabetic foot ulcers.
RESEARCH DESIGN AND 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.
PMID: 12766097 [Indexed for MEDLINE]
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