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COMPRIME: Inelastic Compression in Edema After Revascularization

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05910411
Collaborator
(none)
20
Enrollment
1
Arm
12.2
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Inelastic compression
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inelastic Compression in Edema After Revascularization
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 5, 2023
Anticipated Study Completion Date :
Jul 5, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluating the safety of inelastic compression [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

Secondary Outcome Measures

  1. threshold of cPSI below which the application of inelastic compression results in altered arterial flow. [day 5]

    Determine the threshold of IPSc values before and after compression placement

  2. toe pressure below which the application of inelastic compression results in altered arterial flow. [day 5]

    Determine the toe pressure based on TCPO2 values before and after compression placement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05910411
Other Study ID Numbers:
  • 22-AOIP-02
  • 2022-A02260-43
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphedema

Study Results

No Results Posted as of Jun 18, 2023