Clinical trial NCT00762086: Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
intermittent pneumatic compression treatment
Initial claudication
Lead sponsor: Mego Afek Ltd.
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Absolute Claudication Distance (ACD)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Praxis für Angiology
city: Rottach-Egern
country: Germany
facility: Praxis für Gefäßmedizin am Tegernsee
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Ramat Gan
country: Israel
facility: NARA Medical Center
Study officials:
name: Avigdor Zelikovski, Prof.
role: PRINCIPAL_INVESTIGATOR
References: