Trial Information

Summary: Alprostadil in PAOD Stage IV

Multinational, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Critical Limb Ischemia (Fontaine Stage IV) P

The study is to confirmedly show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations

Inclusion Criteria:

• Subjects with macro-angiopathy, proven PAOD Stage IV with 2 ischaemic skin lesions
• No primary revascularization recommended

Exclusion Criteria:

• Imminent or foreseeable amputation
• History of chronic alcohol or drug abuse
• More than two ischemic ulcerations
• Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
• Neuropathic or venous ulcers
• Buerger's disease

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Trial listings updated: June 1, 2008 at 6:43:17 AM