Detrimental effect of high-dose prostaglandin E1 in the treatment of ischemic ulcers.

Eight patients with ischemic lower extremity ulcers were entered into a randomized, controlled trial of intravenous prostaglandin E1 (PGE1) versus placebo. All ulcers had been stable or increasing in size for at least 3 weeks prior to the study. Each patient had rest pain assessment, Doppler pressure measurements, and ulcer measurements before and after infusion. Four patients received PGE1 and four received placebo. There were no significant preinfusion differences between groups. Rest pain remained stable or improved in all patients. In the placebo group the mean absolute ankle pressure decreased 5 +/- 14 mm Hg, but the mean ankle/arm pressure ratio increased 0.03 +/- 0.06. In the PGE1 group the mean absolute ankle pressure decreased 16 +/- 16 mm Hg and the mean ankle/arm pressure ratio decreased 0.05 +/- 0.06. Neither difference is statistically significant. Patients who received placebo had no change or decrease in ulcer size, but all patients who received PGE1 had an increase in ulcer size (P = 0.05, Wilcoxon rank sum test). One of the four placebo patients required extremity amputation during follow-up of 10.5 +/- 3.5 months. All four patients in the PGE1 group required amputation within 3.3 +/- 2.6 months. Despite theoretic benefits, intravenous PGE1 may be detrimental in the treatment of ischemic ulcers.

RCT Entities:   Population Interventions Outcomes