Conditions: Peripheral Arterial Occlusive Disease
Keywords: Alprostadil Prostavasin PAOD Fontaine Stage IV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 840
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. arm 2: Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.

Interventions: intervention 1: Alprostadil intervention 2: Placebo
Intervention descriptions: intervention 1: * Active Substance: Prostaglandin E1
* Pharmaceutical Form: solution for infusion
* Concentration: 40 μg b.d.
* Route of Administration: intravenous infusion intervention 2: * Active Substance: Lactose
* Pharmaceutical Form: solution for infusion
* Concentration: 40 μg b.d.
* Route of Administration: intravenous infusion

Protocol document: