Abstract
OBJECTIVE: To gain experience in the use of Dermagraft (Advanced Biohealing Inc, La Jolla, California), a human fibroblast-derived dermal substitute (HFDS), for the treatment of nonhealing diabetic foot ulcers (DFUs).
STUDY DESIGN: An open label, noncontrolled, multicenter clinical trial of HFDS in the treatment of DFU was conducted. Subjects with DFUs underwent sharp debridement of the study ulcer and were prescribed an off-loading device. All of the subjects enrolled received applications of HFDS, beginning at day 0 and applied weekly thereafter, along with saline gauze or polyurethane foam dressings from day 0 to week 20. A maximum of 8 HFDS applications was allowed.
MAIN OUTCOME MEASURES: The primary and secondary end points of the study were complete wound closure by weeks 12 and 20, respectively.
MAIN RESULTS: A total of 23 centers screened 91 subjects, and 18 centers enrolled an intent-to-treat (ITT) population of 62 subjects. For the ITT population, 27 (44%) subjects healed by week 12, and 32 (52%) healed by week 20. Fifty-one subjects (82%) completed the study to week 12, and 46 subjects (74%) completed the entire 20-week study; wound closure rates in these groups were 59% and 70%, respectively. Median time to healing was 13 weeks. The overall incidence of at least 1 adverse event (44%, 27/62) was typical for this subject population. No adverse events were attributable to HFDS.
CONCLUSION: Data from this study support the safety and efficacy of HFDS in the treatment of nonhealing DFUs.