Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change from baseline extraction rates at 3 days after wearing MOBIDERM
研究概览
简要总结
MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014). This CE (Conformity European)-marking device is well established both in ambulatory and hospitalisation. Nevertheless, the mechanism of action of this device had never been confirmed and no experimental clinical studies had been performed. The hypothesis is that the MOBIDERM system creates a pressure differential between the contact zone underneath the foam cubes composing the system and their surrounding area, leading to a shear effect on the subcutaneous tissues treated.
The aim of this study is thus to assess the mechanism of action of MOBIDERM on the lymphatic system by evaluating quantitative and qualitative effects of this medical device on lymphatic system, oedema volume and cutaneous parameters in 10 lymphoedema patients during their hospitalisation for reduction phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary lower limb lymphedema of stage 2 or 3 according to the criteria defined by International Society of Lymphology
- •Affected leg that fits with one of the standard sizes of the Auto-Adjustable MOBIDERM® Autofit stocking provided
- •Signed informed consent prior to any study-mandated procedure.
排除标准
- •Pregnant or breastfeeding patient
- •Childbearing age patient without contraception
- •Intolerance to Mobiderm or known allergy to the components used
- •Evolutive lower limb infection
- •Acute lower limb inflammation
- •Dermatological ailment oozing from the treated limb
- •Severe medical condition that may interfere with the proper conduct of the study
- •Advanced diabetic microangiopathy
- •Limb arteritis stage III or IV
- •Decompensated heart failure
- •Involvement in another clinical study
- •Patient mentally incapable of understanding the nature, objectives and possible consequences of the study and / or refusing to submit to the constraints of this trial
结局指标
主要结局
Change from baseline extraction rates at 3 days after wearing MOBIDERM
时间窗: Day : 3
Assess the difference of extraction rate (%) in different areas (ankle, upper and lower middle third of the leg, knee, calf) by lymphoscintigraphy performed at D1 and D3 after wearing MOBIDERM®
次要结局
- Change of lymphatic vascular flow between D1 and D3(Day : 3)
- Change on lymphatic system between H2 and H4 : immediate effect(Hours : 2 and 4)
- Change of vascular lymphatic activity between D1 and D3(Day : 3)
- Change on lymphatic system between D1 and D3 : short term effect(Day : 3)
- Satisfaction regarding MOBIDERM(Day : 3)
- Lymphedema volume reduction between D1 and D3(Days : 1 and 3)
- Cutaneous suppleness between D1 and D3(Days : 1 and 3)
- Number of type of serious and non-serious Adverse Device Effects(Day : 3)
- Skin condition evolution between D1 and D3(Days : 1 and 3)