We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855673
First Posted: March 4, 2009
Last Update Posted: March 4, 2009
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.
Information provided by:
Hospital Universitario Getafe
  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 4

Study Type: Interventional
Study Design: 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

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

  Eligibility

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.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00855673


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

Responsible Party: Joaquin deHaro, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT00855673     History of Changes
Other Study ID Numbers: FM-S1
First Submitted: March 2, 2009
First Posted: March 4, 2009
Last Update Posted: March 4, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases