Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oedema Study : Chroedem (CHROEDEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02914808
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment
Lower Limb Chronic Oedema Other: Patients will undergo a lower limb MRI and blood tests

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?).


Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema




Primary Outcome Measures :
  1. Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area [ Time Frame: 18 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jean-Philippe GALANAUD, MD, PhD 0033447337024 jp-galanaud@chu-montpellier.fr

Locations
Layout table for location information
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         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Jean-Philippe GALANAUD, MD, PhD University Hospital, Montpellier

Layout table for additonal information
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:
Layout table for MeSH terms
Edema
Signs and Symptoms