Intermittent Mechanical Compression For Peripheral Arterial Disease

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Intermittent Mechanical Compression; Drug: Control

• Registration Number: NCT00855673
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-02
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Last Update Submitted: 2009-03-02
• Study First Posted: 2009-03-04
• Last Update Posted: 2009-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Intermittent Mechanical Compression	Active group receiving intermittent compression
Control	Control	Standard Medical Treatment

Primary Outcome Measures

Name	Time	Method
exercise tolerance	3 months

Secondary Outcome Measures

Name	Time	Method
ankle-brachial index	3 months