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.