NCT00855673

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
Last Updated

March 4, 2009

Status Verified

February 1, 2009

Enrollment Period

6.9 years

First QC Date

March 2, 2009

Last Update Submit

March 2, 2009

Conditions

Peripheral Arterial Disease

Keywords

ClaudicationPeripheral Arterial DiseaseIntermittent CompressionMechanical CompressionFlowmedic

Outcome Measures

Primary Outcomes (1)

  • exercise tolerance

    3 months

Secondary Outcomes (1)

  • ankle-brachial index

    3 months

Study Arms (2)

Active

EXPERIMENTAL

Active group receiving intermittent compression

Device: Intermittent Mechanical Compression

Control

ACTIVE COMPARATOR

Standard Medical Treatment

Drug: Control

Interventions

Intermittent Mechanical CompressionDEVICE

FM220 device

Active
ControlDRUG

Standard medical treatment

Control

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable claudication with an absolute claudication distance \>40 meters but \<300
  • resting ABI in the affected limb \<0.8

You may not qualify if:

  • presence of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent Claudication

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joaquin DeHaro, MD

    Hospital Universitario Getafe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

January 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 4, 2009

Record last verified: 2009-02