TREATMENT OF VENOUS LEG ULCERS WITH TOPICAL ILOPROST - A PLACEBO-CONTROLLED STUDY

The disturbed microcirculation is seen as a causative factor in provok ing venous leg ulcers. The stable prostacyclin analogue iloprost has s hown beneficial effects on the disturbed microcirculation after intrav enous infusions. In this study the topical route was chosen in order t o facilitate handling and to reduce the possibility of systemic advers e reactions. The aim of this study was to assess the efficacy and tole rability of two concentrations of iloprost solutions (0.0005% and 0.00 2%). The trial design was a randomized, double-blind, placebo controll ed study in 11 centres in Germany with 49 patients allocated to treatm ent 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 we eks 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.