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NCT00855673 Clinical Trial

Intermittent Mechanical Compression For Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— FM-S1  

Official title:
Intermittent Mechanical Compression For Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00855673
Other study ID # FM-S1
Secondary ID
Status Completed
Phase Phase 4
First received March 2, 2009
Last updated March 2, 2009
Start date January 2001
Est. completion date December 2007

Study information
Verified date February 2009
Source Hospital Universitario Getafe
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Intermittent Mechanical Compression
FM220 device
Drug:
• Control
Standard medical treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Getafe

Outcome
Type Measure Description Time frame Safety issue
Primary exercise tolerance 3 months No
Secondary ankle-brachial index 3 months No
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