Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, intermittent pneumatic compression treatment, Initial claudication
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.
Interventions
DEVICEAngioPress Intermittent pneumatic compression (IPC) Device
Treatment with Intermittent pneumatic compression (IPC) for PAD
OTHERMedications and Standard walking exercises
Aspirin/Clopidegrol and Standard walking exercises
Sponsors
Mego Afek Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Claudication Distance (ACD) | 3 months | 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 |
Countries
Germany, Israel
Participant flow
Recruitment details
Between March 2009 and August 2011, a total of 67 patients were screened and randomized into the study. Patients were recruited from private clinics and clinics affiliated to University Hospitals
Pre-assignment details
Subjects were required to be treated with Aspirin/Clopidogrel for at least one week priot to 1st treatment
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group AngioPress IPC Device | 39 |
| Control Group Aspirin/Clopidegrol and Standard walking exercises | 28 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Ineligible to participate in the study | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Non compliance | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 17 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age Continuous | 70.8 years STANDARD_DEVIATION 6.96 | 67.8 years STANDARD_DEVIATION 11.76 | 69.5 years STANDARD_DEVIATION 9.31 |
| Region of Enrollment Germany | 14 participants | 5 participants | 19 participants |
| Region of Enrollment Israel | 25 participants | 23 participants | 48 participants |
| Sex: Female, Male Female | 12 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 27 Participants | 23 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 39 | 0 / 28 |
| serious Total, serious adverse events | 2 / 39 | 0 / 28 |
Outcome results
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
Time frame: 3 months
Population: ITT cohort
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Absolute Claudication Distance (ACD) | 54.374 Meters | Standard Error 15.3752 |
| Control Group | Absolute Claudication Distance (ACD) | 0.792 Meters | Standard Error 18.0868 |