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NCT Number: NCT05910411

Inelastic Compression in Edema After Revascularization

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France, 06000

Location status: Recruiting

Location contact

Pascal GIORDANA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Inelastic compression

Device

Inelastic compression used in the treatment of lymphedema

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

PASCAL GIORDANA

CONTACT

[email protected]

0492034702

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: COMPRIME

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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