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Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

NCT01007604 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-11-04

No results posted yet for this study

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.

Conditions

  • Intermittent Claudication

Interventions

DEVICE

Peristaltic pulse PCD

Daily use for two hours

OTHER

Exercise and lifestyle counseling

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

Sponsors & Collaborators

  • NormaTec Industries LP

    collaborator INDUSTRY

  • White River Junction Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Sharon R Besso, MS, ARNP · White River Junction Veterans Affairs Medical Center

  • Joseph P Duggan, DPM · White River Junction Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01007604 on ClinicalTrials.gov