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

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.

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: AngioPress Intermittent pneumatic compression (IPC) Device; Other: Medications and Standard walking exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Praxis für Angiology
  • Rottach-Egern, Germany, 83700
    • Praxis für Gefäßmedizin am Tegernsee
• Israel
  • Haifa, Israel
    • Bnai Zion Medical Center
  • Ramat Gan, Israel
    • NARA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment Group; AngioPress Intermittent pneumatic compression (IPC) Device	Device: AngioPress Intermittent pneumatic compression (IPC) Device; Treatment with Intermittent pneumatic compression (IPC) for PAD
OTHER: Control Group; Aspirin/Clopidegrol and Standard walking exercises	Other: Medications and Standard walking exercises; Aspirin/Clopidegrol and Standard walking exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mego Afek Ltd.
• Investigators: Principal Investigator: Avigdor Zelikovski, Prof.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: September 28, 2008
• First Submitted That Met QC Criteria: September 28, 2008
• First Posted (ESTIMATE): September 30, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2012
• Last Update Submitted That Met QC Criteria: August 27, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease; intermittent pneumatic compression treatment; Initial claudication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: HM-AHR-01