Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers: Non-inferiority, Controlled, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Interface Pressure at V3
研究概览
简要总结
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Patient with at least one venous ulcer progressing for at least 4 weeks
- •Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital
- •Informed consent to participate in the study
- •Social security insurance affiliation
排除标准
- •Patients under guardianship
- •Patient with major cognitive disorders incompatible with follow-up of protocol
- •Pregnancy
- •Patient with an open leg ulcer with a Systolic Pressure Index < 0.8
研究组 & 干预措施
Heel included
The bandage is made by including the heel as recommended in routine.
Heel not included
he bandage is made by leaving the heel uncovered.
干预措施: Heel-free bandage (Other)
结局指标
主要结局
Interface Pressure at V3
时间窗: At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)
Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) : * experimental group: uncovered heel * control group: heel covered by the bandage.
次要结局
- Ankle Circumference(Day 0 and the last day at V3 (between week 4 and week 8))
- Interface Pressure at V2(48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks))
- Interface Pressure Between V2 and V3(At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 weeks))
- Patient Satisfaction: Questionnaire(At the last visit of the protocol (Between 4 and 8 weeks))
- Number of Bandage Repairs(Day 0)