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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT00855673
First received: March 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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
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

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
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, see Learn About Clinical Studies.

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

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
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014