Lower Limb Chronic OedemaCHROEDEMNCT02914808
Oedema Study : Chroedem
An observational study of Lower Limb Chronic Oedema, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
The chroedem study is aiming to assess tissue and biomolecular components of chronic lower limb oedema (CO). The investigators working hypothesis is that according to the aetiology of CO, the proportion of oedema \& composition of peri-oedema tissues (fat, muscle, fibrosis/inflammation) might differ and could at least… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lower Limb Chronic Oedema
- What is being tested?
- Patients will undergo a lower limb MRI and blood tests
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Jan 2017to Jul 2026
- Phase
- Observational
- 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
Study population: 24 patients with a CO of PTS origin and 24 patients with a CO of lymphatic origin (primary lymphoedema) will undergo a clinical examination, 3-D laser scanner volumetry of their lower limbs, blood tests and a MRI of lower limb. Main exclusion criteria will be obesity and bilateral CO.
Who may be able to join
- Lower limb CO secondary to PTS or Primary lymphoedema (We will include secondary lymphedema of the lower limbs only if the matcing constraints on age and length of evolution do not allow pairing)
Who cannot join
- Bilateral CO
- Obesity
- Mixed CO (PTS and lymphatic origins)
- CO of other origin : Heart failure, hepatic or renal impairment
- Denutrition
- Contra-indication to MRI
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- Patient not affiliated to French Health Insurance System
- Patient protected by the law
- Patient refusing to participate
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Pr Sophie BLAISE
Grenoble, Isère, 38700
Sophie BLAISE, PhD, (0)476765547 ext. +33, sblaise@chu-grenoble.fr
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
ISABELLE QUERE, MD, PhD, (0)4 67 33 70 25 ext. +33, jp-galanaud@chu-montpellier.fr
- Not yet recruiting
University Hospital Nimes
Nîmes, 30
JEAN CHRISTOPHE JCG GRIS, MD PHD
About this study
Official title: Assessment of Tissue and Biomolecular Complements of Lower Limb Chronic Oedema
The chroedem study is aiming to assess tissue and biomolecular components of chronic lower limb oedema (CO). The investigators working hypothesis is that according to the aetiology of CO, the proportion of oedema \& composition of peri-oedema tissues (fat, muscle, fibrosis/inflammation) might differ and could at least in part explain differences in failure/success of compressive therapies from one patient to another. For that purpose, 24 patients with a post-thrombotic syndrome (PTS)-related oedema and 24 patients with a primary lymphedema will undergo a magnetic resonance imaging (MRI)) of the legs and biological (genetic) testing.
Read the detailed description
Chronic lower limb oedema is the consequence of an abnormal accumulation of fluid in the interstitium located beneath the skin of legs. It is a frequent disease with a significant morbidity (skin infections, leg ulcers…), which can deeply alter patient's quality of life.
On a pathological point of view, current main hypothesis is hemodynamic (i.e. failure of venous and lymphatic return).
Recent data suggest that other factors, particularly genetic ones (genes coding for proteins of inflammation or of fibrosis, for adipogenesis and for lymphangiogenesis…) could influence the development of CO. Stimulation of these mediators varies from one person to another and from one clinical setting to another (i.e. venous insufficiency vs. lymphedema etc…). One can therefore assume that CO is not a homogeneous entity and that the distribution of tissue components varies.
On a therapeutic point of view, this difference in the distribution of tissue components could at least in part explain the differences in effectiveness of compression therapy and in tissue dysmorphia from one person to another and from one type of CO to another.
The study primary objective is to assess and compare by MRI the different tissue components (oedema, fat, muscle, inflammation/fibrosis) of lower limb CO of venous vs. lymphatic origins.
The investigators shall conduct a prospective observational pilot study. 24 patients with a CO of PTS origin and 24 patients with a CO of lymphatic origin (primary lymphoedema) will undergo a clinical examination, 3-D laser scanner volumetry of their lower limbs, blood tests and a MRI of lower limb. Main exclusion criteria will be obesity and bilateral CO. The main primary outcome measure will be the proportion of fat, muscle and oedema assessed by MRI in a pre-determined lower limb area. The main secondary outcome measure will be the prevalence in each group of i) variations in exonic sequence of genes coding for proteins of inflammation/fibrosis, angiogenesis, adipogenesis; ii) variations in exonic sequence of genes reported in the literature as associated with primary lymphoedema.
This study should allow to better characterize tissue structure and inflammatory, adipous and angio-genetic profiles of lower limb CO. The potential therapeutic perspective is to adapt compressive therapies to the type of oedema and to test the impact of new therapies (e.g. anti-inflammatory drugs for oedema with important fibrotic component?).
- Conditions
- Lower Limb Chronic Oedema
- Being tested
- Patients will undergo a lower limb MRI and blood tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will undergo a lower limb MRI and blood testsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start3 Jan 2017
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Chronic OedemaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ISABELLE QUERE, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914808
- Sponsor's protocol ID
- RECHMPL15_0489
- Acronym
- CHROEDEM
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2016
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tissue and Biomolecular Complements of Lower Limb Chronic Oedema
- ClinicalTrials.gov ID
- NCT02914808
- Acronym / sponsor ID
- CHROEDEM / RECHMPL15_0489
- Conditions
- Lower Limb Chronic Oedema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- 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 chroedem study is aiming to assess tissue and biomolecular components of chronic lower limb oedema (CO). The investigators working hypothesis is that according to the aetiology of CO, the proportion of oedema \& composition of peri-oedema tissues (fat, muscle, fibrosis/inflammation) might differ and could at least in part explain differences in failure/success of compressive therapies from one patient to another. For that purpose, 24 patients with a post-thrombotic syndrome (PTS)-related oedema and 24 patients with a primary lymphedema will undergo a magnetic resonance imaging (MRI)) of the legs and biological (genetic) testing.
Detailed description
Chronic lower limb oedema is the consequence of an abnormal accumulation of fluid in the interstitium located beneath the skin of legs. It is a frequent disease with a significant morbidity (skin infections, leg ulcers…), which can deeply alter patient's quality of life.
On a pathological point of view, current main hypothesis is hemodynamic (i.e. failure of venous and lymphatic return).
Recent data suggest that other factors, particularly genetic ones (genes coding for proteins of inflammation or of fibrosis, for adipogenesis and for lymphangiogenesis…) could influence the development of CO. Stimulation of these mediators varies from one person to another and from one clinical setting to another (i.e. venous insufficiency vs. lymphedema etc…). One can therefore assume that CO is not a homogeneous entity and that the distribution of tissue components varies.
On a therapeutic point of view, this difference in the distribution of tissue components could at least in part explain the differences in effectiveness of compression therapy and in tissue dysmorphia from one person to another and from one type of CO to another.
The study primary objective is to assess and compare by MRI the different tissue components (oedema, fat, muscle, inflammation/fibrosis) of lower limb CO of venous vs. lymphatic origins.
The investigators shall conduct a prospective observational pilot study. 24 patients with a CO of PTS origin and 24 patients with a CO of lymphatic origin (primary lymphoedema) will undergo a clinical examination, 3-D laser scanner volumetry of their lower limbs, blood tests and a MRI of lower limb. Main exclusion criteria will be obesity and bilateral CO. The main primary outcome measure will be the proportion of fat, muscle and oedema assessed by MRI in a pre-determined lower limb area. The main secondary outcome measure will be the prevalence in each group of i) variations in exonic sequence of genes coding for proteins of inflammation/fibrosis, angiogenesis, adipogenesis; ii) variations in exonic sequence of genes reported in the literature as associated with primary lymphoedema.
This study should allow to better characterize tissue structure and inflammatory, adipous and angio-genetic profiles of lower limb CO. The potential therapeutic perspective is to adapt compressive therapies to the type of oedema and to test the impact of new therapies (e.g. anti-inflammatory drugs for oedema with important fibrotic component?).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 24 patients with a CO of PTS origin and 24 patients with a CO of lymphatic origin (primary lymphoedema) will undergo a clinical examination, 3-D laser scanner volumetry of their lower limbs, blood tests and a MRI of lower limb. Main exclusion criteria will be obesity and bilateral CO.
Key inclusion criteria (1 listed)
- Lower limb CO secondary to PTS or Primary lymphoedema (We will include secondary lymphedema of the lower limbs only if the matcing constraints on age and length of evolution do not allow pairing)
Key exclusion criteria (9 listed)
- Bilateral CO
- Obesity
- Mixed CO (PTS and lymphatic origins)
- CO of other origin : Heart failure, hepatic or renal impairment
- Denutrition
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 |
|---|---|---|
| Patients will undergo a lower limb MRI and blood tests | Other | – |
Primary outcome
Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area
Time frame: 18 Months
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 3 Oct 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.
ISABELLE QUERE, MD, PhD principal investigator
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Chronic Oedema, run by University Hospital, Montpellier at 3 sites 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 1 inclusion and 9 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 ISABELLE QUERE, MD, PhD ((0)4 67 33 70 25 ext. +33, i-quere@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area (time frame: 18 Months). 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 3 Oct 2025.