Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL)

UCB

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Other: Placebo; Drug: Alprostadil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596752

2005-001970-29 (EudraCT Number)

SP0777

Details and patient eligibility

About

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.

Enrollment: 840 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 2 patient groups, including a placebo group

Alprostadil

Experimental group

Description:

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.

Treatment:

Drug: Alprostadil

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo