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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mego Afek Ltd.
ClinicalTrials.gov Identifier:
NCT00762086
First received: September 28, 2008
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Peripheral Arterial Disease
Device: AngioPress Intermittent pneumatic compression (IPC) Device
Other: Medications and Standard walking exercises

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

Resource links provided by NLM:


Further study details as provided by Mego Afek Ltd.:

Primary Outcome Measures:
  • Absolute Claudication Distance (ACD) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Enrollment: 67
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control Group
Aspirin/Clopidegrol and Standard walking exercises
Other: Medications and Standard walking exercises
Aspirin/Clopidegrol 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762086

Locations
Germany
Praxis für Angiology
Munich, Germany
Praxis für Gefäßmedizin am Tegernsee
Rottach-Egern, Germany, 83700
Israel
Bnai Zion Medical Center
Haifa, Israel
NARA Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Mego Afek Ltd.
Investigators
Principal Investigator: Avigdor Zelikovski, Prof.
  More Information

No publications provided

Responsible Party: Mego Afek Ltd.
ClinicalTrials.gov Identifier: NCT00762086     History of Changes
Other Study ID Numbers: HM-AHR-01
Study First Received: September 28, 2008
Results First Received: July 23, 2012
Last Updated: August 27, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Mego Afek Ltd.:
Peripheral Arterial Disease
intermittent pneumatic compression treatment
Initial claudication

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014