Oedema Study : Chroedem (NCT02914808) | Clinical Trial Compass
RecruitingNot Applicable
Oedema Study : Chroedem
France60 participantsStarted 2017-01-03
Plain-language 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 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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)
Exclusion criteria:
* Bilateral CO
* Obesity
* Mixed CO (PTS and lymphatic origins)
* CO of other origin : Heart failure, hepatic or renal impairment
* Denutrition
* Contra-indication to MRI
* Patient not affiliated to French Health Insurance System
* Patient protected by the law
* Patient refusing to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area