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 randomized single-blind trial of topical ketanserin (Sufrexal, Janssen Pharmaceuticals; n = 69) vs. normal saline (labeled here as placebo; n = 71). All patients were subjected to surgical debridement of necrotic tissue and lavage with normal saline. Wounds were < 100 cm2 in area. Persons with NIDDM and foot ulcers Wagner 2 and 3 with a median of 8 (interquartile 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 previous amputations and surgical debridements during this hospital stay. Average percent reduction in ulcer area at 12 weeks was 87% for ketanserin vs. 63% for placebo (p < 0.001). The regression equations for the least-squares fit to the area (y) 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 were -3.181 +/- 0.98 and -2.016 +/- 0.15. Thus, average daily reduction in ulcer area was 4.5 mm2/day for ketanserin vs. 2.88 mm2/day for placebo. In conclusion, topical ketanserin significantly accelerated wound healing in diabetic neurotrophic foot ulcers when applied as part of a comprehensive healing program.