A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Volume reduction
研究概览
简要总结
To evaluate the safety of the prototype Compression Device in subjects with Oedema
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 80, willing and able to provide written informed consent, and able to wear the device and follow the requirements of the protocol
- •Subjects who have an ankle to brachial pressure index (ABPI) of at least 0.
- •Subjects who suffer from chronic oedema (i.e. CEAP classification of C3, C4 or C5 1.)
- •Subjects who have Chronic Venous Insufficiency (CVI), which has been present for 6 weeks or longer and who have refluxes >0.5 sec in one or more major venous segments, superficial or deep or both (CEAP classification: C3-C5 1.; Ep,s; As,d; Pr).
排除标准
- •Subjects with a history of skin sensitivity to any of the components of the study product.
- •Subjects who have previously been entered into the study before
- •Subjects who have a history of Deep Vein Thrombosis (DVT) within the last 6 months
- •Subjects who have an active leg ulcer (i.e. CEAP classification of C6 1).
- •Subjects with active cardiac disease or significant history of cardiac disease (including history of myocardial infarction, heart failure, valvular disease, arrhythmia and those with a pacemaker or have previously had a pacemaker).
- •Subjects who have initiated treatment or changed the dose within the past month of pharmaceutical agents that reduce clotting e.g. aspirin (except low-dose aspirin), anti-platelets, anti-coagulants and coumarin.
- •Subjects who are currently taking pharmaceutical agents that can modify the amount of leg oedema (e.g., diuretics, dihydropyridine calcium channel blockers, phlebotonic drugs, or fluctuating doses of systemic steroids) or have taken these agents within the last 10 days.
- •Subjects who are pregnant
- •Subjects who have worn compression therapy in the last 48 hours
研究组 & 干预措施
Profile D
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg
干预措施: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs (Device)
Profile A
Device worn; no pressure given (placebo)
干预措施: Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs (Device)
Profile B
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg
干预措施: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs (Device)
Profile C
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg
干预措施: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs (Device)
Profile E
Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg
干预措施: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs (Device)
Profile F
Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg
干预措施: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs (Device)
Profile G
Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg
干预措施: Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs (Device)
结局指标
主要结局
Volume reduction
Oedema reduction
The nature and incidence of adverse events
次要结局
未报告次要终点