Intermittent Mechanical Compression For Peripheral Arterial Disease - Full Text View

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

This study has been completed.

First Received: March 2, 2009 No Changes Posted

Sponsored by:	Hospital Universitario Getafe
Information provided by:	Hospital Universitario Getafe
ClinicalTrials.gov Identifier:	NCT00855673

Purpose

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 IV

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Intermittent Mechanical Compression For Peripheral Arterial Disease

Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:

exercise tolerance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ankle-brachial index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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
Active: Experimental Active group receiving intermittent compression	Device: Intermittent Mechanical Compression FM220 device
Control: Active Comparator Standard Medical Treatment	Drug: Control Standard medical treatment

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855673

Sponsors and Collaborators

Hospital Universitario Getafe

Investigators

Principal Investigator:

Joaquin DeHaro, MD

Hospital Universitario Getafe

More Information

No publications provided

Responsible Party:	Hospital Universitario Getafe ( Joaquin deHaro )
Study ID Numbers:	FM-S1
Study First Received:	March 2, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00855673 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Universitario Getafe:

Claudication
Peripheral Arterial Disease
Intermittent Compression
Mechanical Compression
Flowmedic

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009