Clinical Trials Logo

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.


Clinical Trial 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

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


Related Conditions & MeSH terms


NCT number NCT01007604
Study type Interventional
Source White River Junction VAMC
Contact Sharon R Besso, MS, ARNP
Phone 802-295-9363
Email sharon.besso@va.gov
Status Not yet recruiting
Phase Phase 2
Start date November 2009
Completion date March 2011

See also
  Status Clinical Trial Phase
Recruiting NCT05400395 - Clinical Trial for GNX80 in Intermittent Claudication Phase 4
Active, not recruiting NCT02341716 - Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication N/A
Completed NCT02041169 - Lower Extremity Peripheral Arterial Disease and Exercise Ischemia N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Recruiting NCT00538408 - Whole Body Magnetic Resonance Angiography in Ischemic Patients N/A
Completed NCT00388128 - Caffeine and Intermittent Claudication Phase 3
Completed NCT00618670 - Home-based vs. Supervised Exercise for People With Claudication N/A
Recruiting NCT00146666 - Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD) Phase 2
Completed NCT00134277 - Trial Comparing Different Medical Devices for Infragenual Dilatation N/A
Completed NCT01256775 - Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD) Phase 2
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Recruiting NCT06299956 - Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark N/A
Not yet recruiting NCT05335161 - A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease Phase 1
Completed NCT04390282 - Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication N/A
Completed NCT03271710 - Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System N/A
Completed NCT02380794 - Novel Treatment of Intermittent Claudication in Patients With Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule Phase 2
Active, not recruiting NCT02276937 - Randomized Phase IIb Trial of DVC1-0101 Phase 2
Completed NCT02097082 - Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00071266 - The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC Phase 3