Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

Intermittent Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01007604
• Other study ID #: 21975
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 3, 2009
• Last updated: November 3, 2009
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: November 2009
• Source: White River Junction VAMC
• Contact: Sharon R Besso, MS, ARNP
• Phone: 802-295-9363
• Email: sharon.besso[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

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.

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction VAMC	NormaTec Industries LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak walking time (in seconds) during a graded-protocol treadmill test		initial; 3 months; 6 months	No
Secondary	Claudication onset time (in seconds) during a graded-protocol treadmill test		initial; 3 months; six months	No
Secondary	Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale		initial; 3 months; 6 months	No
Secondary	Ankle-Brachial Index (ABI)		initial; 3 months; 6 months	No
Secondary	Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth		initial; 3 months; 6 months	No