NCT02316210已完成早期 1 期
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Observable foot twitch in response to stimulation with Digitimer DS7A
研究概览
简要总结
This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and over
- •Be a non-responder to the geko MK1&2 device
- •Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
- •Able and willing to follow the protocol requirements.
排除标准
- •Has a pacemaker
- •Is contraindicated for the MK1&2 device and/or the Digitimer DS7A
- •Recently diagnosed or suspected DVT
结局指标
主要结局
Observable foot twitch in response to stimulation with Digitimer DS7A
时间窗: up to 2 hours
Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured
次要结局
- adverse events(up to 2 hours)
- oedema(up to 2 hours)
- patient rated tolerability questionnaire(up to 2 hours)
研究者
研究点 (2)
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