COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855673
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : March 4, 2009
Information provided by:
Hospital Universitario Getafe

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Intermittent Mechanical Compression Drug: Control Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Mechanical Compression For Peripheral Arterial Disease
Study Start Date : January 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active
Active group receiving intermittent compression
Device: Intermittent Mechanical Compression
FM220 device

Active Comparator: Control
Standard Medical Treatment
Drug: Control
Standard medical treatment

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855673

Sponsors and Collaborators
Hospital Universitario Getafe
Layout table for investigator information
Principal Investigator: Joaquin DeHaro, MD Hospital Universitario Getafe
Layout table for additonal information
Responsible Party: Joaquin deHaro, Hospital Universitario Getafe Identifier: NCT00855673    
Other Study ID Numbers: FM-S1
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: March 4, 2009
Last Verified: February 2009
Keywords provided by Hospital Universitario Getafe:
Peripheral Arterial Disease
Intermittent Compression
Mechanical Compression
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases