TOPICAL TREATMENT OF VENOUS LEG ULCERS WITH A PROSTACYCLIN HYDROGEL -A DOUBLE-BLIND TRIAL

In a randomized, double-blind, placebo controlled study in patients wi th venous leg ulcers, the efficacy and tolerability of topical applica tions of a prostacylin hydrogel (iloprost) was investigated. 34 patien ts mere allocated to the placebo treatment and 65 patients mere alloca ted to the iloprost treatment. The iloprost treatment commenced with 1 0 mu g/ml for the first 3 days and mas increased to 40 mu g/ml for the remaining treatment period if well tolerated. Maximally 3 mi of the h ydrogel mere applied daily on the ulcer base for a period of 8 weeks. The total area of the ulcers at the last individual assessment was cho sen as the main criterion for evaluation of efficacy. Both concentrati ons of iloprost were well tolerated with almost the entire trial popul ation on iloprost being treated with the 40 mu g/ml iloprost hydrogel. With regards to efficacy, no significant difference was found in favou r of the iloprost treatment.