Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

November 3, 2009 updated by: White River Junction Veterans Affairs Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • White River Junction VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • Ambulatory exercise
  • Smoking cessation counseling
Experimental: PCD with peristaltic pulse waveform
Daily use for two hours
Device: Peristaltic pulse PCD
Daily use for two hours
Other Names:
  • NormaTec PCD
  • Exercise and lifestyle counselling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Claudication onset time (in seconds) during a graded-protocol treadmill test
Time Frame: initial; 3 months; six months
initial; 3 months; six months
Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale
Time Frame: initial; 3 months; 6 months
initial; 3 months; 6 months
Ankle-Brachial Index (ABI)
Time Frame: initial; 3 months; 6 months
initial; 3 months; 6 months
Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth
Time Frame: initial; 3 months; 6 months
initial; 3 months; 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

White River Junction Veterans Affairs Medical Center

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2009

Last Update Submitted That Met QC Criteria

November 3, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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