Treatment of Claudication With a Peristaltic Pulse Pneumatic Device
Status unconfirmed · Phase 2
Conditions studied: Intermittent Claudication
In brief
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.
Key facts
- Study ID
- NCT01007604
- Run by
- White River Junction Veterans Affairs Medical Center
- People needed
- 50
- Starts
- 2009-11-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2009-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Consistent claudication symptoms for at least 6 months
- ABIs at rest as follows: 0.5>ABI<0.8 minimally on one leg
You may not qualify if…
- 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
Where it is running
- White River Junction VAMC — White River Junction, Vermont, United States
Full record on ClinicalTrials.gov
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