Efficacy Study of a Peristaltic Pulse Pneumatic Device in the Treatment of Claudication
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peak walking time (in seconds) during a graded-protocol treadmill test
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. While anecdotal evidence exists supporting a decrease in claudication symptoms, there are no previously published data on studies employing this compression device in the treatment of arterial disease. The investigators' primary hypothesis is that patients randomized to the intervention arm of the trial will experience an increase in mean walking ability as compared to the group receiving medical standard of care.
详细描述
Peripheral arterial disease (PAD) is a common disorder, affecting 12% of adults older than 50 years of age. Approximately one third of these patients experience intermittent claudication, defined as pain in the thigh or calf muscles during walking and that resolves with rest. Lower extremity pain is often severe enough to significantly limit ambulation, forcing many patients to seek medical care. Current treatments include two FDA-approved medications, supervised walking programs, arterial angioplasty and/or stent placement, and open arterial bypass surgery. The problem is that noninvasive treatments are oftentimes ineffective, while invasive treatments are effective but expensive.
A non-invasive lower extremity treatment that has shown success in treating lymphedema and venous insufficiency will be studied during this protocol to assess its effects on claudication symptoms. Half of the participants in this prospective, single-center randomized controlled trial will be treated with a pneumatic compression device in a home treatment program, while half will receive standard medical therapy. If effective, potential benefits are high, providing relief of personal disability and avoidance of costly surgical intervention.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consistent claudication symptoms for at least 6 months
- •ABIs at rest as follows: 0.5>ABI<0.8 minimally on one leg
排除标准
- •Refuses to consent
- •Unlikely to be compliant with protocol
- •Unable to perform treadmill test
- •Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
- •Lower extremity surgery or endovascular procedure within the last 3 months
- •Currently has a non-healing wound on either leg
- •DVT in the past 3 months
- •Unstable hypertension, angina, uncontrolled glucose levels
- •Participating in a supervised exercise regimen
- •Claudication medications regime changed within the last 3 months
- •Diagnosis of Raynaud's Disease
- •Requires a custom fabricated boot appliance
- •Single limb amputees meeting inclusion criteria may participate in this study
研究组 & 干预措施
Exercise and lifestyle counselling
Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
干预措施: Exercise and lifestyle counseling (Other)
PCD with peristaltic pulse waveform
Daily use for two hours
干预措施: Peristaltic pulse PCD (Device)
结局指标
主要结局
Peak walking time (in seconds) during a graded-protocol treadmill test
时间窗: initial; 3 months; 6 months
次要结局
- Claudication onset time (in seconds) during a graded-protocol treadmill test(initial; 3 months; six months)
- Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale(initial; 3 months; 6 months)
- Ankle-Brachial Index (ABI)(initial; 3 months; 6 months)
- Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth(initial; 3 months; 6 months)