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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AngioPress Intermittent pneumatic compression (IPC) Device
Medications and Standard walking exercises
Sponsored by
Mego Afek Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, intermittent pneumatic compression treatment, Initial claudication

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Praxis für Angiology
  • Praxis für Gefäßmedizin am Tegernsee
  • Bnai Zion Medical Center
  • NARA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Treatment Group

Control Group

Arm Description

AngioPress Intermittent pneumatic compression (IPC) Device

Aspirin/Clopidegrol and Standard walking exercises

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2008
Last Updated
August 27, 2012
Sponsor
Mego Afek Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00762086
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mego Afek Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease, intermittent pneumatic compression treatment, Initial claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
AngioPress Intermittent pneumatic compression (IPC) Device
Arm Title
Control Group
Arm Type
Other
Arm Description
Aspirin/Clopidegrol and Standard walking exercises
Intervention Type
Device
Intervention Name(s)
AngioPress Intermittent pneumatic compression (IPC) Device
Intervention Description
Treatment with Intermittent pneumatic compression (IPC) for PAD
Intervention Type
Other
Intervention Name(s)
Medications and Standard walking exercises
Intervention Description
Aspirin/Clopidegrol and Standard walking exercises
Primary Outcome Measure Information:
Title
Absolute Claudication Distance (ACD)
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avigdor Zelikovski, Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Praxis für Angiology
City
Munich
Country
Germany
Facility Name
Praxis für Gefäßmedizin am Tegernsee
City
Rottach-Egern
ZIP/Postal Code
83700
Country
Germany
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Facility Name
NARA Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

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

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