The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from PAOD stage IV.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment
Timeframe: At 12 weeks after the end of study drug treatment
Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment
Timeframe: At 24 weeks after the end of study drug treatment