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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intermittent Mechanical Compression
Control
Sponsored by
Hospital Universitario Getafe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Claudication, Peripheral Arterial Disease, Intermittent Compression, Mechanical Compression, Flowmedic

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Active

    Control

    Arm Description

    Active group receiving intermittent compression

    Standard Medical Treatment

    Outcomes

    Primary Outcome Measures

    exercise tolerance

    Secondary Outcome Measures

    ankle-brachial index

    Full Information

    First Posted
    March 2, 2009
    Last Updated
    March 2, 2009
    Sponsor
    Hospital Universitario Getafe
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00855673
    Brief Title
    Intermittent Mechanical Compression For Peripheral Arterial Disease
    Acronym
    FM-S1
    Official Title
    Intermittent Mechanical Compression For Peripheral Arterial Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Universitario Getafe

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease
    Keywords
    Claudication, Peripheral Arterial Disease, Intermittent Compression, Mechanical Compression, Flowmedic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active
    Arm Type
    Experimental
    Arm Description
    Active group receiving intermittent compression
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Standard Medical Treatment
    Intervention Type
    Device
    Intervention Name(s)
    Intermittent Mechanical Compression
    Intervention Description
    FM220 device
    Intervention Type
    Drug
    Intervention Name(s)
    Control
    Intervention Description
    Standard medical treatment
    Primary Outcome Measure Information:
    Title
    exercise tolerance
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    ankle-brachial index
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joaquin DeHaro, MD
    Organizational Affiliation
    Hospital Universitario Getafe
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Intermittent Mechanical Compression For Peripheral Arterial Disease

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