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OpenTrials
Completed

NCT Number: NCT00855673

Intermittent Mechanical Compression For Peripheral Arterial Disease

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

Completed

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Mechanical Compression

Device

FM220 device

Control

Drug

Standard medical treatment

Primary outcomes

  1. exercise tolerance

    Time frame: 3 months

Secondary outcomes

  1. ankle-brachial index

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Acronym: FM-S1

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Mar 4, 2009
Registry last updated
Mar 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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