Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Sub-bandage pressure
研究概览
简要总结
Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who could apply the optimal pressure with OEB and CPG-EB.
详细描述
For treatment of venous ulcer, it was shown that compression bandaging of 35-45 mmHg sub-bandage pressure at the ankle was shown in several studies to be safe and effective.The efficacy of compression bandage considerably depends on the applied pressure and it is therefore largely dependent on the individual applying bandages. The lower pressure leads to treatment failure while the higher pressure leads to skin complication.
The use of objective devices to proof that the bandage is sufficiently applied is not available for every patients. To help the patients to apply the bandage with optimal pressure, investigators developed the customized pressure guide elastic bandage (CPG-EB) by using sub-bandage pressure guidance.
Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition,investigators compared the percentage of inexperienced staffs who could apply the optimal pressure with OEB and CPG-EB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic venous insufficiency CEAP (clinical, etiologic, anatomic, and pathophysiologic) C4,C5 and C6
排除标准
- •Patients who can not perform bandaging by themselves
研究组 & 干预措施
ordinary elastic bandage
Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.
干预措施: Ordinary elastic bandage (Device)
customized pressure guide bandage
Bandaging was applied by spiral methods. Three customized pressure guide elastic bandage were applied by stretching until the elliptical shape marker in the bandage turned into circular shape with 50% overlapping from foot to just below knee level.
干预措施: customized pressure guide bandage (Device)
结局指标
主要结局
Sub-bandage pressure
时间窗: 1 hour
次要结局
未报告次要终点