Inelastic Compression in Edema After Revascularization

Not Applicable

Recruiting

• Conditions: Lymphedema
• Interventions: Device: Inelastic compression

• Registration Number: NCT05910411
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-18
• Study Start: 2023-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inelastic compression	Inelastic compression	Inelastic compression used in the treatment of lymphedema

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France