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

NCT00762086 | Completed Results

• 1 other identifier: HM-AHR-01
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 4

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

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; intermittent pneumatic compression treatment; Initial claudication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

AngioPress Intermittent pneumatic compression (IPC) Device

Device: AngioPress Intermittent pneumatic compression (IPC) Device

Control Group

OTHER

Aspirin/Clopidegrol and Standard walking exercises

Other: Medications and Standard walking exercises

Interventions

AngioPress Intermittent pneumatic compression (IPC) Device DEVICE

Treatment with Intermittent pneumatic compression (IPC) for PAD

Treatment Group

Medications and Standard walking exercises OTHER

Aspirin/Clopidegrol and Standard walking exercises

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mego Afek Ltd.: lead

Study Sites (4)

Praxis für Angiology

Munich, Germany

Location

Praxis für Gefäßmedizin am Tegernsee

Rottach-Egern, 83700, Germany

Location

Bnai Zion Medical Center

Haifa, Israel

Location

NARA Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Shmulik Adler
• Organization: A. Stein Regulatory Affairs Consulting

shmulik@asteinrac.com

972-9-767-0002

Study Officials

• Avigdor Zelikovski, Prof.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2008
• First Posted: September 30, 2008
• Study Start: March 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 31, 2012
• Results First Posted: August 27, 2012

Record last verified: 2012-08

Locations

DE (2); IL (2)