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Intermittent Mechanical Compression For Peripheral Arterial Disease (FM-S1)

This study has been completed.
Information provided by:
Hospital Universitario Getafe Identifier:
First received: March 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

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

Condition Intervention Phase
Peripheral Arterial Disease
Device: Intermittent Mechanical Compression
Drug: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Mechanical Compression For Peripheral Arterial Disease

Resource links provided by NLM:

Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • exercise tolerance [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • ankle-brachial index [ Time Frame: 3 months ]

Enrollment: 30
Study Start Date: January 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Active group receiving intermittent compression
Device: Intermittent Mechanical Compression
FM220 device
Active Comparator: Control
Standard Medical Treatment
Drug: Control
Standard medical treatment


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00855673

Sponsors and Collaborators
Hospital Universitario Getafe
Principal Investigator: Joaquin DeHaro, MD Hospital Universitario Getafe
  More Information

Responsible Party: Joaquin deHaro, Hospital Universitario Getafe Identifier: NCT00855673     History of Changes
Other Study ID Numbers: FM-S1
Study First Received: March 2, 2009
Last Updated: March 2, 2009

Keywords provided by Hospital Universitario Getafe:
Peripheral Arterial Disease
Intermittent Compression
Mechanical Compression

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017