跳至主要内容
临床试验/NCT02914808
NCT02914808招募中不适用

Assessment of Tissue and Biomolecular Complements of Lower Limb Chronic Oedema

University Hospital, Montpellier3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
3
主要终点
Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Proportion of fat muscle and oedema assessed by MRI in a pre determined lower limb area

时间窗: 18 Months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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