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

Peripheral Arterial Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762086
• Other study ID #: HM-AHR-01
• Status: Completed
• Phase: N/A
• First received: September 28, 2008
• Last updated: August 27, 2012
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: Mego Afek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• AngioPress Intermittent pneumatic compression (IPC) Device
Treatment with Intermittent pneumatic compression (IPC) for PAD

Other:
• Medications and Standard walking exercises
Aspirin/Clopidegrol and Standard walking exercises

Locations

Country	Name	City	State
Germany	Praxis für Angiology	Munich
Germany	Praxis für Gefäßmedizin am Tegernsee	Rottach-Egern
Israel	Bnai Zion Medical Center	Haifa
Israel	NARA Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Mego Afek Ltd.

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Claudication Distance (ACD)	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	3 months	No