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

Hospital Universitario Getafe

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Device: Intermittent Mechanical Compression; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT00855673

FM-S1

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Active

Experimental group

Description:

Active group receiving intermittent compression

Treatment:

Device: Intermittent Mechanical Compression

Control

Active Comparator group

Description:

Standard Medical Treatment

Treatment:

Drug: Control