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A topical gel formulation of recombinant human platelet-derived growth factor (becaplermin) was recently approved in the U.S. to promote healing of diabetic lower-extremity ulcers. This multicenter, industry-sponsored trial examined the efficacy of this gel in 382 diabetic patients with chronic neuropathic ulcers. The mean ulcer area was 2.7 cm2, and mean duration of the ulcer was 49 weeks.
Patients were randomized to receive becaplermin gel at one of two strengths (100 microg/g or 30 microg/g) or placebo gel, applied once daily to the wound. In addition, all patients received standard wound care, with tissue debridement, daily dressing changes, and treatment of infection. During 20 weeks of treatment, the frequency of complete healing was s…