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Inelastic Compression in Edema After Revascularization

Inelastic Compression in Edema After Revascularization

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05910411
Acronym
COMPRIME
Enrollment
20
Registered
2023-06-18
Start date
2023-12-11
Completion date
2026-06-11
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

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.

Interventions

DEVICEInelastic compression

Inelastic compression used in the treatment of lymphedema

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluating the safety of inelastic compressionday 5no 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

MeasureTime frameDescription
threshold of cPSI below which the application of inelastic compression results in altered arterial flow.day 5Determine the threshold of IPSc values before and after compression placement
toe pressure below which the application of inelastic compression results in altered arterial flow.day 5Determine the toe pressure based on TCPO2 values before and after compression placement

Countries

France

Contacts

Primary ContactPASCAL GIORDANA
giordana.m@chu-nice.fr0492034702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026