Assessing tissue components in chronic lower limb oedema
Assessment of Tissue and Biomolecular Complements of Lower Limb Chronic Oedema
University Hospital, Montpellier · NCT02914808
This study is testing how the tissue in the legs of people with chronic swelling from different causes affects their treatment with compression therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 3 sites (Grenoble, Isère and 2 other locations) |
| Trial ID | NCT02914808 on ClinicalTrials.gov |
What this trial studies
The chroedem study aims to evaluate the tissue and biomolecular components of chronic lower limb oedema (CO) by comparing patients with post-thrombotic syndrome-related oedema to those with primary lymphedema. This observational pilot study will involve 48 patients who will undergo magnetic resonance imaging (MRI) of their legs and genetic testing to understand the differences in tissue composition and how it may affect the success of compression therapies. The study seeks to identify variations in fat, muscle, and inflammation/fibrosis in the affected limbs, which could provide insights into personalized treatment approaches.
Who should consider this trial
Good fit: Ideal candidates include individuals with lower limb chronic oedema due to post-thrombotic syndrome or primary lymphedema.
Not a fit: Patients with bilateral chronic oedema, obesity, or mixed origins of oedema may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, tailored therapies for patients suffering from chronic lower limb oedema.
How similar studies have performed: While the approach of assessing tissue components in chronic oedema is relatively novel, similar studies have shown promise in understanding the complexities of oedema treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Grenoble, Isère and 2 other locations
- Pr Sophie BLAISE — Grenoble, Isère, France (NOT_YET_RECRUITING)
- University Hospital of Montpellier — Montpellier, France (RECRUITING)
- University Hospital Nimes — Nîmes, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: ISABELLE QUERE, MD, PhD — University Hospital, Montpellier
- Study coordinator: ISABELLE QUERE, MD, PhD
- Email: i-quere@chu-montpellier.fr
- Phone: (0)4 67 33 70 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower Limb Chronic Oedema