Inelastic Compression in Edema After Revascularization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inelastic compression.
- Who it may be relevant to
- Registry conditions: Lymphedema. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Inelastic compression
Inelastic compression used in the treatment of lymphedema
Primary outcome measures
- Evaluating the safety of inelastic compression [Time frame: day 5]
Secondary outcome measures (2)
- threshold of cPSI below which the application of inelastic compression results in altered arterial flow. [Time frame: day 5]
- toe pressure below which the application of inelastic compression results in altered arterial flow. [Time frame: day 5]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT05910411 · 22-AOIP-02 · 2022-A02260-43