Topical Human Growth Hormone Treatment of Chronic Leg Ulcers

Abstract

In a double-blind placebo-controlled trial, 37 patients with chronic leg ulceration were randomized to receive either topical human growth hormone, 1 IU cm ⁻² ulcer area, 5 d per week, or placebo, in addition to a standard treatment (compression, hydrocolloid dressing). The two groups were broadly similar in age, sex, initial ulcer area and underlying aetiological variables. During the study 18 patients were withdrawn (six in the growth hormone group and 12 in the placebo group; NS). Eight of them did not complete the 2 weeks of treatment necessary to establish a healing rate and were consequently not included in the analyses of healing. During a mean treatment period of 8 weeks, the healing rate was 16% per week (95% confidence interval 8.7 to 23% per week) in the growth hormone group and 3% per week (−3.4 to 8.4% per week) in the placebo group, (P = 0.02). In 11 patients (61%) in the growth hormone group and two patients (18%) in the placebo group, the ulcer area decreased by 50% during the study (P = 0.03). The treatment was neither accompanied by side-effects nor signs or symptoms indicating a significant absorption of growth hormone. Further studies are needed to address the dose-response relationship and optimal administration frequency of topical growth hormone in the treatment of chronic leg ulcers.