CLINICAL-EVALUATION OF RECOMBINANT HUMAN PLATELET-DERIVED GROWTH-FACTOR FOR THE TREATMENT OF LOWER-EXTREMITY DIABETIC ULCERS

Purpose: The purpose of this study was to investigate the efficacy and safety of recombinant human platelet-derived growth factor (rhPDGF-BB) in a double-blind, placebo-controlled, multicenter study of patients with chronic diabetic ulcers. Methods: Patients with chronic, full-thickness, lower-extremity diabetic neurotrophic ulcers of at least 8 weeks' duration, free of necrotic and infected tissue after debridement, and with transcutaneous oxygen tensions of 30 mm Hg or greater were studied. A total of 118 patients were randomized to receive either topical rhPDGF-BB (2.2 mu g/cm(2) of ulcer area) or placebo until the ulcer was completely resurfaced or for a maximum of 20 weeks, whichever occurred first. Results: Twenty-nine (48%) of 61 patients randomized to the rhPDGF-BB group achieved complete wound healing during the study compared with only 14 (25%) of 57 patients randomized to the placebo group (p = 0.01). The median reduction in wound area in the group given rhPDGF-BB was 98.8% compared with 82.1% in the group given placebo (p = 0.09). There were no significant differences in the incidence or severity of adverse events between the rhPDGF-BB and placebo groups. Conclusions: Once-daily topical application of rhPDGF-BB is safe and effective in stimulating the healing of chronic, full-thickness, lower-extremity diabetic neurotrophic ulcers.