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临床试验/NCT07277010
NCT07277010尚未招募不适用

Building an Artificial Intelligence-Driven Early Warning System and Home Management Protocol for a Diabetic Foot Ulcer Recurrence Cohort

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
1-year recurrence rate of diabetic foot

研究概览

简要总结

Diabetes is one of the major chronic diseases, and diabetic foot ulcer (DFU) is a significant adverse prognosis of diabetes. The recurrence of DFU after healing involves multiple risk factors, such as changes in foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, the degree of ischemia, and control of systemic diseases. Early identification of signs of DFU recurrence and timely follow-up interventions are crucial for improving prognosis, reducing disability rates, and lowering healthcare costs. However, traditional follow-up systems lack individualized strategies (e.g., insufficient risk stratification, rigid follow-up intervals, inadequate compliance management), often resulting in low follow-up efficacy. High-risk patients prone to recurrence may not receive frequent enough follow-ups for early detection, while low-risk patients unlikely to recur may undergo multiple unnecessary visits, increasing the burden on both patients and healthcare providers. This inefficiency is a key reason for the persistently high rates of disability and mortality among patients with recurrent DFU. Establishing individualized follow-up strategies for DFU, leveraging advanced technologies to address core bottlenecks such as delayed recurrence warnings and insufficient home management, represents an effective technical approach to solving these problems.

Our center aims to establish and refine a specialized cohort for active DFU follow-up, along with a multimodal database with comprehensive indicators. We plan to explore a high-risk foot grading system for preventing DFU recurrence and develop targeted follow-up protocols. Using AI technology, we will create a wound alert system capable of identifying DFU recurrence and explore a remote healthcare and AI-assisted prevention and control system for DFU recurrence, centered on patient self-management at home.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • A diagnosis of type 1 or type 2 diabetes in accordance with the definitions set by the World Health Organization;
  • The wound was caused by diabetic foot*. After treatment, the wound healed. The criteria for successful healing were as follows: the wound was dry with no exudate; the wound bed and edges were completely epithelialized; there were no signs of redness or swelling in the surrounding area; and the wound had sufficient tensile strength to withstand pressure without cracking;
  • Voluntarily participated in this study and signed the informed consent form.

排除标准

  • The patient is unable to cooperate or has a mental disorder;
  • At the discretion of the researchers, the subject is not suitable for this study or is unable to comply with the requirements of this study.

结局指标

主要结局

1-year recurrence rate of diabetic foot

时间窗: 1-year

Recurrence rate of diabetic foot = (Number of diabetic foot patients who experience ulcer recurrence within 1 year) / (Total number of diabetic foot patients whose ulcers have healed) × 100%

次要结局

  • Proportion of patients with Wagner grade 1/2 among those who experienced DFU recurrence within 1 year of follow-up(1-year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Long Zhang

Head of Wound Healing Center

Peking University Third Hospital

研究点 (1)

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