A Phase I, Randomized, Open-label, One-arm, Active Controlled Study to Evaluate the Pressure Interface Between Device and Skin of a Compression Device and Profore® on Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To evaluate the amount of pressure and the variability of interface pressure of the two devices on application
研究概览
简要总结
This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •over 18 years, willing and able to provide written informed consent.
- •able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan
- •an ankle to brachial pressure index (ABPI) of 0.9 or greater
- •CEAP classification C0-C2
- •healthy volunteers
排除标准
- •history of skin sensitivity to any of the components of the study product
- •participated in a previous clinical study within the past 3 months
- •active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
- •exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- •leg sizes outside the following range:
- •Ankle - 12cm to 44cm
- •Calf - 22cm to 60cm
- •Below knee - 22cm to 68cm
结局指标
主要结局
To evaluate the amount of pressure and the variability of interface pressure of the two devices on application
时间窗: 3 days
Safety will be evaluated by the nature and frequency of adverse events.
时间窗: 3 days
To evaluate pressure change of the interface pressure with the compression device and Profore® over time
时间窗: 3 days
次要结局
未报告次要终点