Amputation Associated Factors and Prediction Model in Diabetic Foot 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
- 300
- 试验地点
- 1
- 主要终点
- All non-traumatic amputate events
研究概览
简要总结
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.
The aim of this study is to assess factors associated with the occurrence of amputation events in the diabetic foot patients based on a retrospective cohort and to construct a prediction model for patients at high amputated risk.
详细描述
Diabetic foot is one of the major complications observed in patients with diabetes. Diabetic foot can lead to non-traumatic lower-limb amputation (LLA), and is confirmed to be associated with cognitive decline and worsening quality of life. Previous studies indicated that diabetics had a 25% lifetime risk of developing diabetic foot, and 14% to 24% of those require amputation. In patients with poor results of conservative treatment, amputation is the main terminal treatment option to avoid the spread of infection.
Amputation in diabetic foot patients may linked to different causes, including inflammatory, infectious and malignant conditions. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to evaluate the progression and prognosis of diabetic foot patients. A prediction model will be developed to identify high-risk diabetic foot patients of amputation and provide a scientific basis for personalized clinical care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of diabetic foot
- •Hospitalized patients
- •No history of amputation
排除标准
- •Patients with Bone Neoplasms
- •Patients with osteomyelitis not caused by diabetes
- •Patients with amputation caused by severe peripheral vascular disease not caused by diabetes
- •Traumatic Amputations
- •Patients in shock on admission
- •Patients discharged against medical advice
结局指标
主要结局
All non-traumatic amputate events
时间窗: through study completion, an average of 2.2 year
The main outcome was any non-traumatic amputation events among patients with diabetic foots including removing all of a limb or extremity (major amputation) or a portion of a limb or extremity (minor amputation).
次要结局
- Composite outcomes of serious adverse(through study completion, an average of 2.2 year)
- All-cause mortality(through study completion, an average of 2.2 year)
- Length of stay in hospital(through study completion, an average of 2.2 year)