Efficacy of the treatment with prostaglandin E-1 in venous ulcers of the lower limbs.

Background: Venous ulcers represent an important medical problem because of their high prevalence and consequent sanitary costs. In this study, we evaluated the effect of prostaglandin E-1 (PGE-1), a drug that improves district ischemia, on the healing of venous ulcers.

Methods: We performed a randomized, placebo-controlled, single blind study in which 87 patients who had venous leg ulcers homogeneous for dimensions and characteristics were treated for 20 days with an infusion of prostaglandin E-1 or placebo, in association with topical therapy. The dimension and the number of the ulcers were determined at the beginning of the treatment and then every 20 days up to 4 months, or until total recovery. The main outcome of the study was the recovery percentage of the ulcers at the end of the 120-day period of observation and the referred healing time. The reduction in the extension of ulcers from the baseline measurement to the last observation was also evaluated.

Results: The baseline characteristics of the treatment and control groups were similar. The reduction in the size of the ulcers was faster in the patients treated with PGE-1. In this group, 100% of the ulcers healed < or = 100 days, whereas in the placebo group, only 84.2% did so by the end of the 120-day observation period (P < .05). The estimated healing times of 25%, 50%, and 75% of the patients treated with PGE-1 were 23, 49, and 72 days, respectively, compared with 52, 80, and 108 for the patients in the placebo group. Only one serious event occurred in the treated group.

Conclusions: This study demonstrates the effectiveness of PGE-1 in reducing the healing time of venous ulcers, suggesting that venous ulcers should also be considered ischemic.