Treatment of venous leg ulcers with topical iloprost: a placebo controlled study.

The disturbed microcirculation is seen as a causative factor in provoking venous leg ulcers. The stable prostacyclin analogue iloprost has shown beneficial effects on the disturbed microcirculation after intravenous infusions. In this study the topical route was chosen in order to facilitate handling and to reduce the possibility of systemic adverse reactions. The aim of this study was to assess the efficacy and tolerability of two concentrations of iloprost solutions (0.0005% and 0.002%). The trial design was a randomized, double-blind, placebo controlled study in 11 centres in Germany with 49 patients allocated to treatment 1 (placebo solution); 49 patients to treatment 2 (0.0005% iloprost solution) and 50 patients to treatment 3 (0.002% iloprost solution). The study solutions were applied twice weekly for a period of eight weeks on the ulcer edge and ulcer surrounding. This study failed to show any statistically significant reduction in the ulcer size as a result of the iloprost treatment compared to the placebo treatment. Possible reasons for the findings are discussed.