CompletedPhase 4

Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

Czechia, Germany, Mexico840 participantsStarted 2004-03

Plain-language summary

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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is at least 45 years of age * Subjects with macro-angiopathy, proven PAOD Stage IV with up to 2 ischaemic skin lesions for more than 2 weeks * Subject has a complete angiography of pelvis, thigh and calf within one month of inclusion * Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis of the lower limb artery * Subject is not in the position to be primarily revascularized or refuses surgery Exclusion Criteria: * Imminent or foreseeable amputation * Major amputation on the affected extremity * History of chronic alcohol or drug abuse * More than two ischemic ulcerations * One ulcer ≥ 6 cm\^2, both ulcers ≤ 1 cm\^2 or at least one ulcer affecting the bone or tendons * Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin * Neuropathic or venous ulcers * Buerger's disease * Septic gangrene * Use of vasoactive medication or prostaglandins * Treatment with prostanoids within 3 months prior to inclusion * Surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00596752

SponsorUCB BIOSCIENCES GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

Results submitted2014-05-05

View on ClinicalTrials.gov More Peripheral Arterial Occlusive Disease trials