Treatment of chronic ulcers in the lower extremities with topical becaplermin gel .01%: a multicenter open-label study.

This prospective, multicenter, open-label study assessed the efficacy and tolerability of recombinant human platelet-derived growth factor BB (becaplermin) in the treatment of chronic ulcers of the lower extremities in 73 patients with and without type 2 diabetes mellitus. Becaplermin gel .01% was applied once daily for 12 weeks. Efficacy was assessed in terms of progression to healing (100% epithelialization); the secondary efficacy endpoint was time to complete healing. Safety was assessed in terms of incidence of adverse events. Ninety-five percent of all ulcers were completely healed at week 9; only 5% remained incompletely healed at week 12 and were considered treatment failures. Healing time did not differ between diabetic and nondiabetic patients. The major adverse events were pain, burning sensation, and pruritus at the ulcer site, with an overall incidence of 10%. No patients dropped out because of adverse events. Becaplermin gel .01% was safe and well tolerated. Further studies are necessary to assess the durability of healing with this treatment.