NCT05051540已完成不适用
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in the Quality of Life as Measured by CIVIQ-20
研究概览
简要总结
The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures
- •Subject must have chronic venous insufficiency of stages C3, C4, or C5 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification system
- •Not compliant with their currently prescribed compression system
排除标准
- •Active malignancy other than non-melanoma skin cancer
- •Study ulcer suspicious for cancer
- •Subjects who are pregnant and/or breastfeeding
- •In the opinion of the PI the subject cannot comply with study procedures
结局指标
主要结局
Change in the Quality of Life as Measured by CIVIQ-20
时间窗: Baseline to 6 weeks
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) consists of 20 multiple choice questions subdivided into four categories: psychology, pain, physical repercussions and social repercussions. The questionnaire has a total score ranging from 0 to 100 the lower score indicating greater quality of life.
次要结局
未报告次要终点
研究者
Hadar Lev-Tov
Assistant Professor of Clinical
University of Miami
研究点 (2)
Loading locations...
相似试验
招募中
不适用
The effect of elastic compression stockings on nocturia induced by leg edemaJPRN-UMIN000041909niversity of the Ryukyus100
撤回
不适用
A Clinical Study to Assess a Compression Device in Patients With Venous Leg UlcersVaricose UlcerNCT025610133M
已完成
不适用
Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes MellitusLeg EdemaDiabetes MellitusPeripheral Arterial DiseaseNCT03384758University Hospital Erlangen94
Unknown
不适用
Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar ArthrodesisFoot ArthritisNCT04784156MedShape, Inc60
Unknown
不适用
The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar ArthrodesisFoot ArthritisNCT04338607MedShape, Inc60