The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers
Results of a prospective randomized trial
- William A. Marston, MD1,
- Jason Hanft, DPM2,
- Paul Norwood, MD3,
- Richard Pollak, DPM4 and
- for the Dermagraft Diabetic Foot Ulcer Study Group
- 1University of North Carolina School of Medicine, Chapel Hill, North Carolina
- 2Foot & Ankle Institute of South Florida, South Miami, Florida
- 3Valley Endocrine, Fresno, California
- 4University of Texas Health Science Center, San Antonio, Texas; and the Dermagraft Joint Venture, La Jolla, California
Abstract
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.
Footnotes
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Address correspondence and reprint requests to William Marston, Campus Box 7212, 210 Burnett-Womack, University of North Carolina, Chapel Hill, NC 27599-7212. E-mail: sky{at}med.unc.edu.
Received for publication 23 December 2002 and accepted in revised form 10 March 2003.
W.A.M. is on the speaker’s bureau for Smith and Nephew, Inc., and has received honoraria and travel support for lectures and travel programs from Smith and Nephew, Inc. J.H. has received consulting fees for lectures and program sponsorship from Advanced Tissue Sciences, holds stock in ATIS, and has been a paid speaker for Smith and Nephew, Inc.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
- DIABETES CARE
