Angiosome Perfusion After Tibial Bypass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
研究概览
简要总结
Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.
详细描述
Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.
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
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at CLI Rutherford stages IV to VI
- •Patients with necessity of tibial Bypass surgery
排除标准
- •Allergy against indocyanine green
- •Iodine allergy
- •Contrast allergy
- •Penicillin allergy
- •Allergic diathesis
- •Liver insufficiency
- •Pregnancy
- •Hyperthyreosis
- •Pulmonary arterial hypertension
研究组 & 干预措施
foot perfusion
intravenous application of indocyanine green in patients receiving tibial Bypass surgery
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
时间窗: 12 months
Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery
Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)
时间窗: 12 months
Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery
次要结局
- Correlation of the wound healing rates with indirect and direct revascularization(12 months)
研究者
Ulrich Rother
Dr. med. Ulrich Rother, Principal Investigator
University Hospital Erlangen