Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II

NCT ID: NCT00762086

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-01-31

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; intermittent pneumatic compression treatment; Initial claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Group

AngioPress Intermittent pneumatic compression (IPC) Device

Group Type: ACTIVE_COMPARATOR

AngioPress Intermittent pneumatic compression (IPC) Device

Intervention Type: DEVICE

Treatment with Intermittent pneumatic compression (IPC) for PAD

Control Group

Aspirin/Clopidegrol and Standard walking exercises

Group Type: OTHER

Medications and Standard walking exercises

Intervention Type: OTHER

Aspirin/Clopidegrol and Standard walking exercises

Interventions

AngioPress Intermittent pneumatic compression (IPC) Device

Treatment with Intermittent pneumatic compression (IPC) for PAD

Intervention Type: DEVICE

Medications and Standard walking exercises

Aspirin/Clopidegrol and Standard walking exercises

Intervention Type: OTHER

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
• Subject after crural or pedal bypass surgery
• Subject with neuropathy
• Uncontrolled arterial hypertension
• Morbid obesity (BMI >35.0)
• Need for concomitant medication with potential vascular activity
• Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc)
• Expected weak compliance
• Subject requires surgical or endovascular intervention for PAD
• Subject has known allergy to device components (sleeve fabric).
• Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis).
• Subject participates in any other clinical study at the same time

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mego Afek Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Avigdor Zelikovski, Prof.

Role: PRINCIPAL_INVESTIGATOR

Locations

Praxis für Angiology

Munich, , Germany

Praxis für Gefäßmedizin am Tegernsee

Rottach-Egern, , Germany

Bnai Zion Medical Center

Haifa, , Israel

NARA Medical Center

Ramat Gan, , Israel

Countries

Germany; Israel

Other Identifiers

HM-AHR-01

Identifier Type: -

Identifier Source: org_study_id