Clinical trial NCT01007604: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intermittent Claudication
Keywords: claudication
pneumatic compression device
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: NormaTec Industries LP
First posted: 2009-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peak walking time (in seconds) during a graded-protocol treadmill test
timeFrame: initial; 3 months; 6 months
Secondary outcomes:
measure: Claudication onset time (in seconds) during a graded-protocol treadmill test
timeFrame: initial; 3 months; six months
measure: Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale
timeFrame: initial; 3 months; 6 months
measure: Ankle-Brachial Index (ABI)
timeFrame: initial; 3 months; 6 months
measure: Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth
timeFrame: initial; 3 months; 6 months
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Sharon R Besso, MS, ARNP
role: PRINCIPAL_INVESTIGATOR
affiliation: White River Junction Veterans Affairs Medical Center
name: Joseph P Duggan, DPM
role: PRINCIPAL_INVESTIGATOR
References: