Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy Study of a Peristaltic Pulse Pneumatic Device in the Treatment of Claudication

Conditions
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Intermittent Claudication

Intervention / Treatment
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* Device: Peristaltic pulse PCD
* Other: Exercise and lifestyle counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consistent claudication symptoms for at least 6 months ABIs at rest as follows: 0.5>ABI<0.8 minimally on one leg Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise and lifestyle counselling<br>Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation. | Other: Exercise and lifestyle counseling<br>* Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.<br>* Other names: Smoking cessation counseling;|
| Experimental: PCD with peristaltic pulse waveform<br>Daily use for two hours | Device: Peristaltic pulse PCD<br>* Daily use for two hours<br>* Other names: Exercise and lifestyle counselling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak walking time (in seconds) during a graded-protocol treadmill test |  | initial; 3 months; 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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claudication, pneumatic compression device