Oedema Study : Chroedem (CHROEDEM)
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| ClinicalTrials.gov Identifier: NCT02914808 |
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Recruitment Status :
Recruiting
First Posted : September 26, 2016
Last Update Posted : February 8, 2019
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| Condition or disease | Intervention/treatment |
|---|---|
| Lower Limb Chronic Oedema | Other: Patients will undergo a lower limb MRI and blood tests |
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 Type : | Observational |
| Estimated Enrollment : | 48 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Tissue and Biomolecular Complements of Lower Limb Chronic Oedema |
| Actual Study Start Date : | January 3, 2017 |
| Estimated Primary Completion Date : | August 3, 2019 |
| Estimated Study Completion Date : | December 2019 |
- Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area [ Time Frame: 18 Months ]
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion criteria:
- Lower limb CO secondary to PTS or Primary lymphoedema
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914808
| Contact: Jean-Philippe GALANAUD, MD, PhD | 0033447337024 | jp-galanaud@chu-montpellier.fr |
| France | |
| GALANAUD | Recruiting |
| Montpellier, France, 34295 | |
| Contact: JEAN PHILIPPE GALANAUD, MD, PhD 0033447 337 024 jp-galanaud@chu-montpellier.fr | |
| University Hospital Nimes | Not yet recruiting |
| Nimes, France, 30 | |
| Contact: JEAN CHRISTOPHE JCG GRIS, MD PHD | |
| Principal Investigator: | Jean-Philippe GALANAUD, MD, PhD | University Hospital, Montpellier |
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT02914808 History of Changes |
| Other Study ID Numbers: |
UF 9667 |
| First Posted: | September 26, 2016 Key Record Dates |
| Last Update Posted: | February 8, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Edema Signs and Symptoms |