A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients: A Retrospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,301
- 试验地点
- 1
- 主要终点
- New-onset diabetic foot
研究概览
简要总结
A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model.
详细描述
Diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. Diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. Early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality.
Most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. This study aims to conduct a retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes
- •Hospitalized patients
- •The interval between two records is more than one year
排除标准
- •Any history of ulcer or amputation previously
- •The patients with type 1 diabetes
- •Pregnant during the study
- •Patients with malignant tumors
- •Complicated with serious organ dysfunction, such as heart, liver and kidney
结局指标
主要结局
New-onset diabetic foot
时间窗: through study completion, an average of 32 months
Diabetic foot was defined based on the self-reported disease history and clinical diagnosis from the electronic medical records. New-onset diabetic foot was diagnosed as the first-episode during the study period.
次要结局
未报告次要终点
研究者
Yibing Wang
professor
Qianfoshan Hospital