Inelastic Compression in Edema After Revascularization

NCT05910411 | Recruiting

• 2 other identifiers: 22-AOIP-022022-A02260-43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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

  day 5

Secondary Outcomes (2)

• threshold of cPSI below which the application of inelastic compression results in altered arterial flow.

  day 5

• toe pressure below which the application of inelastic compression results in altered arterial flow.

  day 5

Study Arms (1)

Inelastic compression

EXPERIMENTAL

Inelastic compression used in the treatment of lymphedema

Device: Inelastic compression

Interventions

Inelastic compression DEVICE

Inelastic compression used in the treatment of lymphedema

Inelastic compression

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• arterial bypasses under the leg or distal joints
• critical ischemia
• patients operated on for acute ischemia
• pregnant or breast-feeding women
• severe cardiac insufficiency
• \) 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• PASCAL GIORDANA

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PASCAL GIORDANA

CONTACT

0492034702; giordana.m@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 18, 2023
• Study Start: December 11, 2023
• Primary Completion: June 1, 2026
• Study Completion: June 11, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)