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.
Verified date | August 2012 |
Source | Mego Afek Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Mego Afek Ltd. |
Germany, Israel,
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 |
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