SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
研究概览
简要总结
This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency.
The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.
In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Male or post-menopausal women over the age of 65
- •Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
- •Indication of a compression therapy by medical compression stocking
排除标准
- •Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index <0.8 or >1.3
- •Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
- •Advanced heart insufficiency (NYHA III-IV)
- •Contraindications to compression therapy
- •Known allergies to any components of the stocking material
- •Inability to follow the procedures of the study
研究组 & 干预措施
SOCKNLEG
Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
干预措施: SOCKNLEG (Device)
SOCKNLEG
Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
干预措施: Sigvaris COTTON (Device)
Sigvaris COTTON
Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
干预措施: SOCKNLEG (Device)
Sigvaris COTTON
Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
干预措施: Sigvaris COTTON (Device)
结局指标
主要结局
Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
时间窗: 1 day, during study visit
The SSI is a substraction of the Interface Pressures measured with a pressure probe on the leg of the study participant in standing and in supine position while wearing a compression stocking. The point cB1 is a thereby a standard measuring point at the distal insertion of the gastrocnemius muscle of the leg.
次要结局
- Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg(1 day, during study visit)
- Dynamic Stiffness Index (DSI) values of both stockings in mmHg(1 day, during study visit)
- Venous ejection fraction (VEF) of both stockings in %(1 day, during study visit)
- Interface Pressures at point cB on the leg in mmHg(1 day, during study visit)