SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Donning success.
研究概览
简要总结
The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.
详细描述
The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers: age > 18 years, proband information read, consent form signed
- •Patients: age > 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age > 18 year, patient information read, consent signed.
排除标准
- •Active venous ulcer
- •Peripheral arterial disease
- •Peripheral neuropathy
结局指标
主要结局
Donning success.
时间窗: Successful donning has to be completed within 5 minutes.
Ability to fully done the investigated compression devices.
次要结局
- Interface pressure(Interface pressure is measured within 5 minutes of complete donning of the stocking.)