NCT03636867已完成不适用
Prospective Evaluation of Laboratory, Cellular and Molecular Determinants of Clinical Success of the Treatment in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI) Study
Maria Cecilia Hospital1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2018年8月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Incidence of amputation
研究概览
简要总结
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.
详细描述
All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome:
- medical history, cardiovascular risk factors, clinical presentation
- information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease
- information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing
- blood sample to obtain DNA, RNA and serum
- patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection
- atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease All clinical variables and information obtained from blood/tissue samples will be related to outcome.
Any adverse events will be judged by an independent blinded committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •diagnosis of diabetes mellitus in treatment with oral agents and/or insulin
- •diagnosis of critical limb ischemia requiring medical and/or interventional treatment
排除标准
- •diagnosis or suspicion of malignancy
- •life expectancy <1 year
- •inability to guarantee clinical follow-up
结局指标
主要结局
Incidence of amputation
时间窗: 1-year
Occurrence of major or minor amputation
次要结局
- Wound healing(1-year)
- Incidence of revascularization of peripheral arteries(1-year)
- Change in WIfI class(1-year)
- Change in Rutherford class(1-year)
研究者
研究点 (1)
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