Ketanserin in the treatment of diabetic foot ulcer with severe peripheral vascular disease.

The aim of this study was to evaluate if ketanserin, a selective serotoninantagonist, could improve wound healing in diabetic patients with foot ulcers and severe peripheral vascular disease. In a double blind study 40 diabetic patients with foot ulcer and a systolic toe pressure below 45 mmHg were randomly allocated to either ketanserin (20-40 mg three times a day) or placebo for a period of 3 months. The treatment was carried out on an out-patient basis by a combined medical/orthopedic foot care team at the Department of Internal Medicine, University Hospital, Lund, Sweden. Both groups were comparable regarding age, sex, duration and treatment of diabetes, cardiovascular disease and type of lesion. Wound healing (defined as intact skin for at least 3 months) or wound size reduction of 50% or more were sen in 11 out of 19 (58%) in the ketanserin group and in 7 out of 19 (37%) in the placebo group. Gangrene developed in 6 patients with placebo and 2 with ketanserin. Two patients died during the study and their ulcers were not evaluated. The systolic toe pressure was measured at admission, at end of run in, after 1 month and 3 months with strain gauge technique. Only one out of nine patients (11%) with a toe pressure below 30 mmHg in the placebo group healed or improved their ulcers compared to nine out of 16 (56%) in the ketanserin group. The healing rate in the ketanserin group was higher than expected considering the lower systolic toe pressure in this group compared to placebo at randomization (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)