A Prospective, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of a New Intermittent Pneumatic Compression Device on Initial Claudication Distance in Patients With Peripheral Arterial Disease Stage II.

Mego Afek Ltd.4 sites in 2 countries67 target enrollmentMarch 2009

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Mego Afek Ltd.
Enrollment: 67
Locations: 4
Primary Endpoint: Absolute Claudication Distance (ACD)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II

Detailed Description

Patients with Peripheral Arterial Disease (PAD) suffer from symptoms such as intermittent claudication, limb and foot pain and tissue lesions, which are difficult to treat. In recent years, there have been reports demonstrating reduction of these symptoms by use of compressible sleeve devices. This clinical study aims at demonstrating the safety and effectiveness of this device in treating PAD symptoms.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

January 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mego Afek Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subject 18 to 90 years, of any race.
•Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg)
•Subject with stable (\>3 month) PAD Fontaine Stage II.
•Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (\<30 days) clinical examination
•Subject has intermittent claudication and claudication pain of the calf
•Subject has stable intermittent claudication (\>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade)
•Subject willing to participate as evidenced by signing the written informed consent.
•Treatment with Aspirin or Clopidogrel for at least 7 days
•Willingness to undergo standardized walking exercise

Exclusion Criteria

•Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms.
•Inability to walk
•Chronic respiratory insufficiency (severe obstructive or restrictive)
•Coronary artery disease with angina
•Stroke, myocardial infarction or other acute vascular events in the last 3 months
•Mild-Severe congestive heart failure
•Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking
•Spinal stenosis or disc lesions with lower limb motor sensory defects
•Leg trauma, limb or skin infection or edema
•Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery

Outcomes

Primary Outcomes

Absolute Claudication Distance (ACD)

Time Frame: 3 months

Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters