Intermittent Mechanical Compression For Peripheral Arterial Disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00855673

Acronym

FM-S1

Enrollment

Registered

2009-03-04

Start date

2001-01-31

Completion date

2007-12-31

Last updated

2009-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Claudication, Peripheral Arterial Disease, Intermittent Compression, Mechanical Compression, Flowmedic

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

Interventions

DEVICEIntermittent Mechanical Compression

FM220 device

DRUGControl

Standard medical treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
exercise tolerance	3 months

Secondary

Measure	Time frame
ankle-brachial index	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026