Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy

Topically applied recombinant human platelet-derived growth factor-BB (beca plermin) is a new pharmacologically active therapy for chronic, neuropathic , lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the pre sent study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients a chieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month p eriod following healing, and treatment compliance. Complete healing of ulce rs was achieved in 57.5% of patients, with a mean time to closure of 63 day s and a recurrence rate of 21% at 6 months. Of the potential factors affect ing ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0. 05), and baseline total wound evaluation score (p < 0.05) were significantl y associated with healing. Results of this study further confirm the effica cy and safety of becaplermin gel for the treatment of lower extremity diabe tic ulcers.