NCT06979037招募中不适用
Clinical Investigation of Genetic Markers in Diabetic Ulcers and Their Role in Personalized Treatment Targeting
The First Affiliated Hospital of University of South China1 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2024年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Ulcer Healing Time
研究概览
简要总结
This clinical trial involves collecting peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients for bioinformatics analysis to screen genetic markers significantly associated with ulcer risk and healing differences. Furthermore, multi-omics data will be integrated to establish a diabetic ulcer risk prediction model. Based on key single nucleotide polymorphisms and their regulatory pathways, potential new drug targets for promoting healing will be explored, providing a genetic basis for personalized treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects who voluntarily participate in this clinical study and sign informed consent;
- •Patients with type 2 diabetes and diabetic ulcers;
- •Disease duration ≥ 10 years or age ≥ 55 years at enrollment;
- •Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study.
排除标准
- •Severe vascular occlusion or impairment;
- •Patients with congenital heart disease, aortic dissection, or other severe cardiovascular diseases;
- •Patients with ulcers caused by factors other than diabetes;
- •Patients with severe liver and kidney dysfunction or serious neurological impairment.
结局指标
主要结局
Ulcer Healing Time
时间窗: Three years
次要结局
- Ulcer Recurrence(Three years)
- Absolute Change in Ulcer Area(Three years)
- Number of Amputation Events(Three years)
- Number of Foot Infections(Three years)
- Time to Complete Wound Closure(Three years or wound closure)
- Quality of Life Assessment(Three years)
- Length of Stay(Three years)
研究者
研究点 (1)
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