NCT00855673CompletedPhase 4
Intermittent Mechanical Compression For Peripheral Arterial Disease
Hospital Universitario Getafe0 sites30 target enrollmentStarted: January 2001Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- exercise tolerance
Study Overview
Brief Summary
The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease.
Major endpoints are improved exercise tolerance and relevant blood pressure ratios
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stable claudication with an absolute claudication distance >40 meters but <300
- •resting ABI in the affected limb <0.8
Exclusion Criteria
- •presence of diabetes
Arms & Interventions
Active
Experimental
Active group receiving intermittent compression
Intervention: Intermittent Mechanical Compression (Device)
Control
Active Comparator
Standard Medical Treatment
Intervention: Control (Drug)
Outcomes
Primary Outcomes
exercise tolerance
Time Frame: 3 months
Secondary Outcomes
- ankle-brachial index(3 months)
Investigators
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