Treatment of Claudication With a Peristaltic Pulse Pneumatic Device
Primary Purpose
Intermittent Claudication
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peristaltic pulse PCD
Exercise and lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring claudication, pneumatic compression device
Eligibility 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
Sites / Locations
- White River Junction VAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Exercise and lifestyle counselling
PCD with peristaltic pulse waveform
Arm Description
Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
Daily use for two hours
Outcomes
Primary Outcome Measures
Peak walking time (in seconds) during a graded-protocol treadmill test
Secondary Outcome Measures
Claudication onset time (in seconds) during a graded-protocol treadmill test
Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale
Ankle-Brachial Index (ABI)
Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth
Full Information
NCT ID
NCT01007604
First Posted
November 3, 2009
Last Updated
November 3, 2009
Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
NormaTec Industries LP
1. Study Identification
Unique Protocol Identification Number
NCT01007604
Brief Title
Treatment of Claudication With a Peristaltic Pulse Pneumatic Device
Official Title
Efficacy Study of a Peristaltic Pulse Pneumatic Device in the Treatment of Claudication
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
NormaTec Industries LP
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
claudication, pneumatic compression device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise and lifestyle counselling
Arm Type
Active Comparator
Arm Description
Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
Arm Title
PCD with peristaltic pulse waveform
Arm Type
Experimental
Arm Description
Daily use for two hours
Intervention Type
Device
Intervention Name(s)
Peristaltic pulse PCD
Other Intervention Name(s)
NormaTec PCD, Exercise and lifestyle counselling
Intervention Description
Daily use for two hours
Intervention Type
Other
Intervention Name(s)
Exercise and lifestyle counseling
Other Intervention Name(s)
Ambulatory exercise, Smoking cessation counseling
Intervention Description
Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
Primary Outcome Measure Information:
Title
Peak walking time (in seconds) during a graded-protocol treadmill test
Time Frame
initial; 3 months; 6 months
Secondary Outcome Measure Information:
Title
Claudication onset time (in seconds) during a graded-protocol treadmill test
Time Frame
initial; 3 months; six months
Title
Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale
Time Frame
initial; 3 months; 6 months
Title
Ankle-Brachial Index (ABI)
Time Frame
initial; 3 months; 6 months
Title
Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth
Time Frame
initial; 3 months; 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon R Besso, MS, ARNP
Phone
802-295-9363
Ext
6390
Email
sharon.besso@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph P Duggan, DPM
Phone
802-295-9363
Ext
5289
Email
joseph.duggan@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon R Besso, MS, ARNP
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph P Duggan, DPM
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VAMC
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon R Besso, MS, ARNP
Phone
802-295-9363
Ext
6390
Email
sharon.besso@va.gov
First Name & Middle Initial & Last Name & Degree
Joseph P Duggan, DPM
Phone
802-295-9363
Ext
5289
Email
joseph.duggan@va.gov
First Name & Middle Initial & Last Name & Degree
Sharon R Besso, MS, ARNP
First Name & Middle Initial & Last Name & Degree
Joseph P Duggan, DPM
First Name & Middle Initial & Last Name & Degree
Caroline Whittington, DPM
12. IPD Sharing Statement
Learn more about this trial
Treatment of Claudication With a Peristaltic Pulse Pneumatic Device
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