A Multicenter Case Control Study of Biomarkers in Diabetic Chronic Wounds Based on Combined Multi-omics Analysis Techniques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 930
- 试验地点
- 1
- 主要终点
- Bioindicators with differences among groups
研究概览
简要总结
This study aims to discover, verify and evaluate the potential biomarkers with regard to the diagnosis, prognostic and/or prediction of diabetic chronic wounds.
详细描述
Investigators will conduct a multicenter prospective case control study consisting of three stages.
In the first stage, investigators will collect clinical data and blood, urine and stool samples from diabetic patients with chronic wound (CWD), diabetic patient without newly identified wound (NWD) and patients without diabetes (ND to discover the candidate bioindicator with differences through combined high-throughput non targeted detection.
In the second stage, investigators will expand the sample size and collect the clinical data and biological samples (blood, urine and stool) of the CWD,NWD and ND participants to verify the difference of the candidate bioindicator in the first stage by targeted technologies.
In the third stage, investigators will collect the clinical data and biological samples (blood, urine and stool) of the CWD and NWD participants to evaluate the value of these candidate bioindicators as biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75;
- •Signed the informed consent form；
- •Subjects in the ND group are the healthy participants without diabetes；
- •Subjects in the NWD group are the diabetic participants without newly identified wounds；
- •Subjects in the CWD group are the diabetic participants with chronic wounds
排除标准
- •With sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney;
- •No diabetes but combined with lower limb arterial stenosis, occlusion or other conditions affecting wound healing or other causes of wounds such as varicose veins in the lower limbs;
- •Special exclusion criteria for blood, urine and stool samples taking.
结局指标
主要结局
Bioindicators with differences among groups
时间窗: Through study completion, an average of 1 year
Analysis omics results and discover candidate bioindicators that differ between groups
Basic clinical and demographic information of participants in groups
时间窗: Through study completion, an average of 1 year
Collect basic clinical and demographic information of participants in groups by a CRF
次要结局
未报告次要终点
研究者
Yibing Wang
professor
Qianfoshan Hospital