Inelastic Compression in Edema After Revascularization

Lymphedema Clinical Trial

— COMPRIME  

Official title:

Inelastic Compression in Edema After Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910411
• Other study ID #: 22-AOIP-02
• Secondary ID: 2022-A02260-43
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: PASCAL GIORDANA
• Phone: 0492034702
• Email: giordana.m[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Inelastic compression
Inelastic compression used in the treatment of lymphedema

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	threshold of cPSI below which the application of inelastic compression results in altered arterial flow.	Determine the threshold of IPSc values before and after compression placement	day 5
Secondary	toe pressure below which the application of inelastic compression results in altered arterial flow.	Determine the toe pressure based on TCPO2 values before and after compression placement	day 5