N/A
N=67
Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00762086 ↗Enrolled (actual)
67
Serious AEs
3.0%
Results posted
Aug 2012
Primary outcome: Primary: Absolute Claudication Distance (ACD) — 54.374; 0.792 Meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AngioPress Intermittent pneumatic compression (IPC) Device (Device); Medications and Standard walking exercises (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mego Afek Ltd.
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Claudication Distance (ACD) |
54.374; 0.792 | — |
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
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 ( 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
Data sourced from ClinicalTrials.gov (NCT00762086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.