Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

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.

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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.

Conditions

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Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise and lifestyle counselling

Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.

Group Type ACTIVE_COMPARATOR

Exercise and lifestyle counseling

Intervention Type OTHER

Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.

PCD with peristaltic pulse waveform

Daily use for two hours

Group Type EXPERIMENTAL

Peristaltic pulse PCD

Intervention Type DEVICE

Daily use for two hours

Interventions

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Peristaltic pulse PCD

Daily use for two hours

Intervention Type DEVICE

Exercise and lifestyle counseling

Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.

Intervention Type OTHER

Other Intervention Names

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NormaTec PCD Exercise and lifestyle counselling Ambulatory exercise Smoking cessation counseling

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No