Skin Microcirculation in Patients With Lower Limb Atherosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in skin microvascular oxygen saturation (SmvO2)
研究概览
简要总结
The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal angioplasty (PTA). Microvascular data from patients and healthy case matched controls at baseline will be compared.15 patients and 15 healthy case matched controls will be enrolled.
详细描述
This clinical investigation is designed as a prospective study of limb skin nutritive capillary perfusion and oxygen extraction in patients with lower limb atherosclerosis and severe symptoms before and following elective PTA.
15 patients with critical lower limb atherosclerosis and ischemia in Rutherford grade 3 - 6 undergoing PTA, as well as 15 healthy case matched controls will be enrolled. Measurements will be performed at baseline, prior to PTA, immediately after PTA, 1 day and 30 days post PTA. Healthy case matched controls will be measured at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Lower limb atherosclerosis and ischemia in Rutherford grade 3-6
- •Obstructive infra-inguinal arterial lesions combined with open distal part of the anterior tibial artery
- •Scheduled for elective PTA
- •Able to give informed consent
排除标准
- •Active skin infection at the region of interest (site to be examined, dorsum of hand and foot)
结局指标
主要结局
Changes in skin microvascular oxygen saturation (SmvO2)
时间窗: From baseline to 40 days post PTA
Changes in functional Capillary Density (FCD)
时间窗: From baseline to 40 days post PTA.
次要结局
- Incidence of AE/ADE/SAE/SADE/DD(From baseline to 40 days post PTA)