NCT04159844Unknown不适用
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- SSI(Static Stiffness Index) ≥ 10 mmHg
研究概览
简要总结
This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.
详细描述
Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness.
The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with a body mass index of less than 30 (BMI = kg / m²),
- •Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
- •Subject presenting a venous doppler of the lower limbs without detectable anomaly
- •Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
- •Subject accepting to wear a compressive system on both legs for a period of three days.
排除标准
- •Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases)
- •Subject with type I or II diabetes
- •Subject with lipoedema and / or dismorphic leg
- •Subject presenting ankle ankylosis
结局指标
主要结局
SSI(Static Stiffness Index) ≥ 10 mmHg
时间窗: Hour 48 after the application
% of subject with a SSI≥ 10 mmHg
次要结局
- SSI (Static Stiffness Index)(From Hour 0 (Baseline) to Hour 72 (end of study) after application)
- Slippage of the bandage in cm(From Hour 0 (Baseline) to Hour 72 (end of study) after application)
- Interface pressure under the bandage(From Hour 0 (Baseline) to Hour 72 after application)
研究者
研究点 (2)
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