Inelastic Compression in Edema After Revascularization

NCT ID: NCT05910411

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2026-06-11

Brief Summary

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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

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Conditions

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Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inelastic compression

Inelastic compression used in the treatment of lymphedema

Group Type EXPERIMENTAL

Inelastic compression

Intervention Type DEVICE

Inelastic compression used in the treatment of lymphedema

Interventions

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Inelastic compression

Inelastic compression used in the treatment of lymphedema

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PASCAL GIORDANA

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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PASCAL GIORDANA

Role: CONTACT

0492034702

Other Identifiers

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2022-A02260-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-AOIP-02

Identifier Type: -

Identifier Source: org_study_id

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