NCT07185048尚未招募不适用
Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,512
- 主要终点
- Incidence of Diabetic Foot Ulcers
研究概览
简要总结
For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years but < 80 years;
- •Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3);
- •Capable of using a smartphone to take photos and operate apps, or able to do so after simple training;
- •Willing to participate in the study and sign an informed consent form.
排除标准
- •Currently has an open foot wound or an unresolved foot ulcer;
- •History of major lower limb amputation above the ankle joint;
- •Pregnancy or breastfeeding;
- •Currently suffering from poorly controlled malignant tumors;
- •Receiving glucocorticoid or immunosuppressive therapy;
- •Diagnosed with vascular occlusive vasculitis;
- •Presence of foot fracture;
- •Significant visual impairment affecting image acquisition or operation;
- •Other conditions deemed inappropriate for participation in this study by the research team.
研究组 & 干预措施
Low-Intensity Digital Foot Care Group
Experimental
干预措施: Digital Foot Care (Low-Intensity) (Behavioral)
Moderate-Intensity Digital Foot Care Group
Experimental
干预措施: Digital Foot Care (Moderate-Intensity) (Behavioral)
Conventional Foot Care Control Group
Active Comparator
干预措施: Conventional Foot Care Control Group (Behavioral)
结局指标
主要结局
Incidence of Diabetic Foot Ulcers
时间窗: 18 months after intervention initiation
次要结局
未报告次要终点
研究者
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