Treatment of Claudication With a Peristaltic Pulse Pneumatic Device
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Exercise and lifestyle counselling Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation. |
Other: Exercise and lifestyle counseling
Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
Other Names:
|
| Experimental: PCD with peristaltic pulse waveform Daily use for two hours |
Device: Peristaltic pulse PCD
Daily use for two hours
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Peak walking time (in seconds) during a graded-protocol treadmill test [initial; 3 months; 6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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:
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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
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Participating in a supervised exercise regimen
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Claudication medications regime changed within the last 3 months
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Diagnosis of Raynaud's Disease
-
Requires a custom fabricated boot appliance
-
Single limb amputees meeting inclusion criteria may participate in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | White River Junction VAMC | White River Junction | Vermont | United States | 05009 |
Sponsors and Collaborators
- White River Junction Veterans Affairs Medical Center
- NormaTec Industries LP
Investigators
- Principal Investigator: Sharon R Besso, MS, ARNP, White River Junction Veterans Affairs Medical Center
- Principal Investigator: Joseph P Duggan, DPM, White River Junction Veterans Affairs Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21975