RANDOMIZED SINGLE-BLIND TRIAL OF TOPICAL KETANSERIN FOR HEALING ACCELERATION OF DIABETIC FOOT ULCERS

The objective of this study was to determine the efficacy of topically applied ketanserin for healing acceleration of diabetic foot ulcers. From August 1993 to September 1994, 140 NIDDM patients entered a rando mized single-blind trial of topical ketanserin (Sufrexal, Janssen Phar maceuticals; n = 69) vs. normal saline (labeled here as placebo; n = 7 1). All patients were subjected to surgical debridement of necrotic ti ssue and lavage with normal saline. Wounds were <100 cm(2) in area. Pe rsons with NIDDM and foot ulcers Wagner 2 and 3 with a median of 8 (in terquartile range 4 - 26) weeks duration were included. Ulcer area was measured at 0, 4, 8 and 12 weeks. The groups were similar in age, sex , years of diabetes duration, obesity, ulcer Wagner type, number of pr evious amputations and surgical debridements during this hospital stay . Average percent reduction in ulcer area at 12 weeks was 87% for keta nserin vs. 63% for placebo (p <0.001). The regression equations for th e least-squares fit to the area Or) against time (x) data points were y = 43.46-3.181x (r = -0.995) for ketanserin and y = 39.46-2.016x (r = -0.999) for placebo (p <0.01). The 95% confidence limits for slopes w ere -3.181 +/- 0.98 and -2.016 +/- 0.15. Thus, average daily reduction in ulcer area was 4.5 mm(2)/day for ketanserin vs. 2.88 mm(2)/day for placebo. In conclusion, topical ketanserin significantly accelerated wound healing in diabetic neurotrophic foot ulcers when applied as par t of a comprehensive healing program.