Topical becaplermin: new preparation. A slight short-term help for some diabetic patients

(1) The reference curative treatment for chronic ulcers in diabetic patients is to avoid pressure on the lesions, and to give appropriate local care. (2) A topical gel containing 0.01% becaplermin, a cell growth factor, is now marketed in Europe for the treatment of chronic neuropathic ulcers measuring less than 5 cm2 in diabetic patients. (3) The clinical file mainly comprises four trials, two of which were double-blind, testing two concentrations. In the largest trial, which gave the most favourable results, the lesions healed completely after 20 weeks in 50% of patients, compared with 35% of patients who used the excipient gel and received local care. (4) The optimal concentration of becaplermin gel is not known. Neither is its effect on lesions larger than 5 cm2 or its ability to prevent the need for amputation. (5) None of the clinical trials revealed any severe adverse effects (particularly tumour growth), but pharmacovigilance data are limited. (6) In practice, the very expensive topical becaplermin gel can help some patients, in whom it slightly accelerates ulcer healing.