Intravenous prostaglandin E1 in the treatment of venous ulcers--a double-blind, placebo-controlled trial.

To assess the clinical efficacy of i.v. PGE1 in the treatment of refractory venous ulcers a double-blind, placebo-controlled study was carried out. 42 patients were given at random either one i.v. infusion of 3 ampoules of Prostavasin (60 micrograms PGE1) or 3 ampoules of placebo (1940.1 micrograms alpha-CD) daily, soluted in 250 ml saline over 3 h. The treatment period was 6 weeks. In the PGE1 group (n = 20) there was a significant improvement in the ulcer status compared to placebo (n = 22) (p less than 0.001) being assessed by a detailed, multivariated score. Ulcers healed completely in 8 out of 20 patients on PGE1 (40%) compared to only 2 out of 22 patients on placebo (9%). Concomitant clinical symptoms improved accordingly. Whereas in the PGE1 group edema were completely resolved in 17 out of 20 patients (85%) this was the case in 7 out of 20 patients of the placebo group (35%). Calf cramps and eczema vanished in 80% and 87.5% respectively under PGE1, but only in 50% and 9% respectively under placebo. Parallel to this an increase of the tcPO2 in the ulcer area of a mean of 45.9% was observed. Throughout the whole treatment period no side effects were noted after PGE1 infusion.