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Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

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ClinicalTrials.gov Identifier: NCT01007604
Recruitment Status : Unknown
Verified November 2009 by White River Junction Veterans Affairs Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2009
Last Update Posted : November 4, 2009
Sponsor:
Collaborator:
NormaTec Industries LP
Information provided by:
White River Junction Veterans Affairs Medical Center

Study Description
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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
Intermittent Claudication Device: Peristaltic pulse PCD Other: Exercise and lifestyle counseling 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Study of a Peristaltic Pulse Pneumatic Device in the Treatment of Claudication
Study Start Date : November 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Peak walking time (in seconds) during a graded-protocol treadmill test [ Time Frame: initial; 3 months; 6 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007604


Contacts
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Contact: Sharon R Besso, MS, ARNP 802-295-9363 ext 6390 sharon.besso@va.gov
Contact: Joseph P Duggan, DPM 802-295-9363 ext 5289 joseph.duggan@va.gov

Locations
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United States, Vermont
White River Junction VAMC
White River Junction, Vermont, United States, 05009
Contact: Sharon R Besso, MS, ARNP    802-295-9363 ext 6390    sharon.besso@va.gov   
Contact: Joseph P Duggan, DPM    802-295-9363 ext 5289    joseph.duggan@va.gov   
Principal Investigator: Sharon R Besso, MS, ARNP         
Principal Investigator: Joseph P Duggan, DPM         
Sub-Investigator: Caroline Whittington, DPM         
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
NormaTec Industries LP
Investigators
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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
More Information
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Responsible Party: Sharon Besso, ARNP, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT01007604    
Other Study ID Numbers: 21975
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: November 4, 2009
Last Verified: November 2009
Keywords provided by White River Junction Veterans Affairs Medical Center:
claudication
pneumatic compression device
Additional relevant MeSH terms:
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Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases