Inelastic Compression in Edema After Revascularization (COMPRIME)

March 18, 2025 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06000
        • Recruiting
        • Chu de Nice
        • Contact:
          • Pascal GIORDANA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients over 18 years of age
  2. arteriopathic patients requiring femoropopliteal revascularization by bypass surgery who have been revascularized
  3. signature of an informed consent
  4. person affiliated or beneficiary of a social security plan

Exclusion Criteria:

  1. arterial bypasses under the leg or distal joints
  2. critical ischemia
  3. patients operated on for acute ischemia
  4. pregnant or breast-feeding women
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inelastic compression
Inelastic compression used in the treatment of lymphedema
Device: Inelastic compression
Inelastic compression used in the treatment of lymphedema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the safety of inelastic compression
Time Frame: day 5
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
day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
threshold of cPSI below which the application of inelastic compression results in altered arterial flow.
Time Frame: day 5
Determine the threshold of IPSc values before and after compression placement
day 5
toe pressure below which the application of inelastic compression results in altered arterial flow.
Time Frame: day 5
Determine the toe pressure based on TCPO2 values before and after compression placement
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: PASCAL GIORDANA, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 11, 2026

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-AOIP-02
  • 2022-A02260-43 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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