Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of successfully dressed medical stockings per subject
研究概览
简要总结
Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.
The present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.
详细描述
Subjects: 40 consenting patients >65y old, with CEAP C4-6 chronic venous insufficiency
Stockings:
One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)
Gliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •> 65 years old Chronic venous insufficiency CEAP C4-6
排除标准
- •Dementia Blindness Paraplegia
研究组 & 干预措施
Test series of 6 types of gliding aids
Each study subjects tests a series of gliding aids or stocking butlers:
- 4 gliding aids
- 2 stocking "butlers", one with and without handle
- 3 medical compression stockings with open tip, compression class 3 (36-46mmHg)
- 3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)
- 2 superimposed stockings with closed tip, compression class 1 (18-21 mmHg)
干预措施: Gliding aids for medical compression stockings (Device)
结局指标
主要结局
Number of successfully dressed medical stockings per subject
时间窗: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
The primary end point is straight: The medical stocking is dressed (at the patient's leg) or it is not dressed. Each gliding aid and each stocking "butler" is tested with this end point.
次要结局
- Patient satisfaction by gliding aid or stocking butler (score)(Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months)