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Inelastic Compression in Edema After Revascularization (COMPRIME)

Primary Purpose

Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inelastic compression
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients over 18 years of age arteriopathic patients requiring femoropopliteal revascularization by bypass surgery who have been revascularized signature of an informed consent person affiliated or beneficiary of a social security plan Exclusion Criteria: arterial bypasses under the leg or distal joints critical ischemia patients operated on for acute ischemia pregnant or breast-feeding women severe cardiac insufficiency 5) severe peripheral neuropathy 6) allergies to the components of the tapes 7) persons deprived of liberty by judicial or administrative decision 8) persons under legal protection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Inelastic compression

    Arm Description

    Inelastic compression used in the treatment of lymphedema

    Outcomes

    Primary Outcome Measures

    Evaluating the safety of inelastic compression
    no skin complications OR a drop in toe blood pressure and/or transcutaneous oxygen pressure (TCPO2) and/or TMS of 20% before and after placement of the compression

    Secondary Outcome Measures

    threshold of cPSI below which the application of inelastic compression results in altered arterial flow.
    Determine the threshold of IPSc values before and after compression placement
    toe pressure below which the application of inelastic compression results in altered arterial flow.
    Determine the toe pressure based on TCPO2 values before and after compression placement

    Full Information

    First Posted
    June 2, 2023
    Last Updated
    June 15, 2023
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05910411
    Brief Title
    Inelastic Compression in Edema After Revascularization
    Acronym
    COMPRIME
    Official Title
    Inelastic Compression in Edema After Revascularization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 5, 2023 (Anticipated)
    Study Completion Date
    July 5, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The appearance of revascularization edema of the lower limb is a frequent complication in peripheral vascular surgery. It can lead to a delay in healing and even to trophic disorders. The prevention and treatment of this complication have so far been limited to postural measures (elevation of the limbs), in the absence of other recommendations and given the contraindication of elastic compression. Inelastic compression is another mode of compression sometimes used in the treatment of lymphedema. It exerts a stable continuous pressure regardless of the patient's position. The investigator's aim is to demonstrate that compression with inelastic bands, applied under good conditions, does not have a major effect on distal arterial vascularization in arterial patients who have undergone revascularization by supra-articular bypass or endovascular treatment of the lower limb.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inelastic compression
    Arm Type
    Experimental
    Arm Description
    Inelastic compression used in the treatment of lymphedema
    Intervention Type
    Device
    Intervention Name(s)
    Inelastic compression
    Intervention Description
    Inelastic compression used in the treatment of lymphedema
    Primary Outcome Measure Information:
    Title
    Evaluating the safety of inelastic compression
    Description
    no skin complications OR a drop in toe blood pressure and/or transcutaneous oxygen pressure (TCPO2) and/or TMS of 20% before and after placement of the compression
    Time Frame
    day 5
    Secondary Outcome Measure Information:
    Title
    threshold of cPSI below which the application of inelastic compression results in altered arterial flow.
    Description
    Determine the threshold of IPSc values before and after compression placement
    Time Frame
    day 5
    Title
    toe pressure below which the application of inelastic compression results in altered arterial flow.
    Description
    Determine the toe pressure based on TCPO2 values before and after compression placement
    Time Frame
    day 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients over 18 years of age arteriopathic patients requiring femoropopliteal revascularization by bypass surgery who have been revascularized signature of an informed consent person affiliated or beneficiary of a social security plan Exclusion Criteria: arterial bypasses under the leg or distal joints critical ischemia patients operated on for acute ischemia pregnant or breast-feeding women severe cardiac insufficiency 5) severe peripheral neuropathy 6) allergies to the components of the tapes 7) persons deprived of liberty by judicial or administrative decision 8) persons under legal protection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MARION CAUSERET
    Phone
    0492034702
    Email
    marioncauseret@yahoo.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    PASCAL GIORDANA
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Inelastic Compression in Edema After Revascularization

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