NCT01634815终止不适用
Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.
University Hospital, Strasbourg, France4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年2月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
研究概览
简要总结
Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.
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
- 否
入选标准
- •Ischemia Chronic critical lower limb revascularization procedure requiring fast.
- •Written consent informed patient age greater than or equal to 18
排除标准
- •Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
- •Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)
- •presence of sensory neuropathy, and / or
- •foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
- •history of foot ulceration, and / or
- •antecedent of one of these factors (ie antécedant diabetic foot).
- •Necrosis of the toes.
- •Participation in another clinical research protocol.
- •Presence of peripheral arterial disease in the bilateral upper limbs.
- •Patient in shock whatever the cause.
- •Presence of hepatic failure.
- •Too impaired general condition (bedridden, dementia, ...)
- •Refusal of the patient to participate in the study
- •Protected patients
研究组 & 干预措施
lactate group
Experimental
干预措施: The Edge (Procedure)
结局指标
主要结局
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
时间窗: 48 hours
Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD) before revascularization of the lower limb in chronic critical limb ischemia (considered positive if\> 2).
次要结局
- The decrease in the ratio LCO/LCD(48 hours)
研究者
研究点 (4)
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