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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 78
- 主要终点
- Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alprostadil
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.
干预措施: Alprostadil (Drug)
Placebo
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.
干预措施: Placebo (Other)
结局指标
主要结局
Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment
时间窗: At 12 weeks after the end of study drug treatment
The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.
Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment
时间窗: At 24 weeks after the end of study drug treatment
Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.
次要结局
- Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment(At 24 weeks after the end of study drug treatment)
- Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment(At 24 weeks after the end of study drug treatment)
- All-cause Mortality During the Course of the Study (up to 196 Days)(During the course of the study (up to 196 days))
- Minor Amputations at 24 Weeks After the End of Study Drug Treatment(At 24 weeks after the end of study drug treatment)
- Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)(During the course of the study (up to 196 days))
- Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment(At 24 weeks after the end of study drug treatment)
- Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment(At 24 weeks after the end of study drug treatment)
- Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment(At 24 weeks after the end of study drug treatment)
- Cardiovascular Mortality During the Course of the Study (up to 196 Days)(During the course of the study (up to 196 days))
- Cardiovascular Morbidity During the Course of the Study (up to 196 Days)(During the course of the study (up to 196 days))