Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m
研究概览
简要总结
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
详细描述
Chronic limb-threatening ischemia (CLTI), the end-stage of lower extremity artery disease (LEAD), occurs with growing prevalence around the globe and is associated with increased healthcare costs. CLTI is defined by the presence of LEAD in combination with rest pain, gangrene, or lower limb ulceration lasting more than two weeks. Despite unclear results of abdominal surgical lumbar sympathectomy, novel interventional minimally invasive fluoroscopy-guided procedures seem to be promising. A prospective interventional study will be conducted, primarily targeting patients afflicted by critical limb ischemia, with the incorporation of thermal vision control and tissue oxygen monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 months with intensity (VAS >=5)
- •those who (only if a signature was obtainable), or whose legal guardian,fully understood the clinical trial -details and signed the informed consent form
排除标准
- •Chronic Venous Insufficiency
- •women with positive a pregnancy tests before the trial or who planned to become pregnant within the following 3 years
- •other patients viewed as inappropriate by the staff
- •disagreement with participation in the study
结局指标
主要结局
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m
时间窗: 3 months follow-up
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m measured by VAS 10 point measurement
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m
时间窗: 3 months follow-up
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m
时间窗: 6 months follow-up
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m
时间窗: 6 months follow-up
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
次要结局
未报告次要终点