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.