NCT02253186已完成不适用
Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in excess arm volume
研究概览
简要总结
The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
- •Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
- •Lymphoedema with evident pitting sign (assessed as ++ or +++)
- •Requiring compression therapy for, at least, the next 3 months.
- •Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
- •Signed informed consent prior to any study-mandated procedure.
- •Not under any administrative or legal supervision.
- •Covered by a health insurance system
排除标准
- •Stage I lymphoedema
- •Active cellulitis
- •Lymphoedema associated with active cancer needing acute chemotherapy
- •Motor and sensitive neurological deficiency
- •Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
- •Patient participating in any other clinical study
- •Unlikely to be followed up to 3 months with clinical assessment
结局指标
主要结局
Change in excess arm volume
时间窗: between Day 0 and Day 30
Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula
次要结局
未报告次要终点
研究者
研究点 (2)
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