LymphedemaCOMPRIMENCT05910411
Inelastic Compression in Edema After Revascularization
A study testing Inelastic compression in people with Lymphedema, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Inelastic compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2023to 11 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, France, 06000
Pascal GIORDANA
About this study
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
- Being tested
- Inelastic compression
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inelastic compressionDevice
Inelastic compression used in the treatment of lymphedema
| Study group | Role | What they receive |
|---|---|---|
| Inelastic compression | Experimental | Inelastic compression used in the treatment of lymphedema Receives: Device: Inelastic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 5
Secondary outcomes (2)
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
Measured: day 5
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
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start11 Dec 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion11 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PASCAL GIORDANA, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910411
- Sponsor's protocol ID
- 22-AOIP-02
- Other IDs
- 2022-A02260-43
- Acronym
- COMPRIME
- Status last verified
- Mar 2025
- First submitted
- 2 Jun 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inelastic Compression in Edema After Revascularization
- ClinicalTrials.gov ID
- NCT05910411
- Acronym / sponsor ID
- COMPRIME / 22-AOIP-02
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 11 Jun 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inelastic compression | Experimental | Device: Inelastic compressionInelastic compression used in the treatment of lymphedema |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- arterial bypasses under the leg or distal joints
- critical ischemia
- patients operated on for acute ischemia
- pregnant or breast-feeding women
- severe cardiac insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inelastic compressionInelastic compression used in the treatment of lymphedema | Device | Inelastic compression |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PASCAL GIORDANA principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inelastic compression in people with Lymphedema, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PASCAL GIORDANA (0492034702, giordana.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the safety of inelastic compression (time frame: day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.