NCT00762086已完成不适用
A Prospective, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of a New Intermittent Pneumatic Compression Device on Initial Claudication Distance in Patients With Peripheral Arterial Disease Stage II.
Mego Afek Ltd.5 个研究点 分布在 2 个国家目标入组 67 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 5
- 主要终点
- Absolute Claudication Distance (ACD)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
详细描述
Patients with Peripheral Arterial Disease (PAD) suffer from symptoms such as intermittent claudication, limb and foot pain and tissue lesions, which are difficult to treat. In recent years, there have been reports demonstrating reduction of these symptoms by use of compressible sleeve devices.
This clinical study aims at demonstrating the safety and effectiveness of this device in treating PAD symptoms.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject 18 to 90 years, of any race.
- •Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg)
- •Subject with stable (>3 month) PAD Fontaine Stage II.
- •Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination
- •Subject has intermittent claudication and claudication pain of the calf
- •Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade)
- •Subject willing to participate as evidenced by signing the written informed consent.
- •Treatment with Aspirin or Clopidogrel for at least 7 days
- •Willingness to undergo standardized walking exercise
排除标准
- •Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms.
- •Inability to walk
- •Chronic respiratory insufficiency (severe obstructive or restrictive)
- •Coronary artery disease with angina
- •Stroke, myocardial infarction or other acute vascular events in the last 3 months
- •Mild-Severe congestive heart failure
- •Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking
- •Spinal stenosis or disc lesions with lower limb motor sensory defects
- •Leg trauma, limb or skin infection or edema
- •Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery
- •Subject after crural or pedal bypass surgery
- •Subject with neuropathy
- •Uncontrolled arterial hypertension
- •Morbid obesity (BMI >35.0)
- •Need for concomitant medication with potential vascular activity
- •Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc)
- •Expected weak compliance
- •Subject requires surgical or endovascular intervention for PAD
- •Subject has known allergy to device components (sleeve fabric).
- •Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis).
- •Subject participates in any other clinical study at the same time
结局指标
主要结局
Absolute Claudication Distance (ACD)
时间窗: 3 months
Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters
次要结局
未报告次要终点
研究者
研究点 (5)
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