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临床试验/NCT07452354
NCT07452354尚未招募不适用

Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot 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3月15日最近更新:
干预措施

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
One-year recurrence rate of diabetic foot

研究概览

简要总结

Diabetic foot ulcer (DFU) is a major adverse outcome of diabetes, which itself is one of the most significant chronic diseases. The recurrence of DFU involves multiple risk factors, including altered foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, degree of ischemia, and systemic disease control. Early identification of recurrence signs 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-such as risk stratification, inflexible follow-up intervals, and insufficient compliance management-often resulting in suboptimal outcomes. High-risk patients prone to recurrence may not be followed up frequently enough for early detection, while low-risk patients may undergo unnecessary visits, increasing burdens on both patients and healthcare providers. This inefficiency contributes significantly to the persistently high rates of disability and mortality among recurrent DFU patients.

Establishing an individualized follow-up strategy for DFU, supported by advanced technology to address core bottlenecks such as delayed recurrence warnings and inadequate home-based management, represents an effective technical pathway to tackle these issues.

Our center proposes to develop a dedicated DFU cohort with comprehensive active follow-up and a multimodal database encompassing well-defined indicators. We aim to explore a high-risk foot grading system for preventing DFU recurrence and design targeted follow-up protocols. By leveraging AI technology, we intend to build a wound warning system capable of identifying DFU recurrence. Furthermore, we seek to establish a telemedicine and AI-assisted, patient-centered home-based self-management framework for early warning and prevention of DFU recurrence.

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

  • The patient must be aged 18 years or older; have a confirmed diagnosis of type 1 or type 2 diabetes mellitus according to the World Health Organization criteria; the wound etiology attributable to diabetic foot ulcers, with complete wound healing post-treatment defined as a dry wound devoid of exudate, complete epithelialization of both the wound bed and margins, absence of surrounding erythema or edema, and sufficient tensile strength to withstand pressure without dehiscence; voluntary participation in this study with provision of written informed consent.

排除标准

  • Inability of the patient to cooperate or presence of psychiatric disorders; At the investigator's discretion, the subject is deemed unsuitable for this study or unable to comply with the study requirements.

研究组 & 干预措施

DFU Healed

The wound etiology was diabetic foot. Post-treatment clinical assessment confirmed complete wound healing, characterized by epithelialization of the wound bed and margins, absence of exudation, no evidence of periwound erythema or edema, and the restoration of adequate tensile strength to withstand physiological stress without dehiscence.

干预措施: Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies. (Diagnostic Test)

结局指标

主要结局

One-year recurrence rate of diabetic foot

时间窗: one year

The recurrence rate of diabetic foot ulcers (%) = (The number of diabetic foot ulcer patients with recurrence within one year / The total number of diabetic foot ulcer patients included in the observation and whose ulcers have healed) × 100%

次要结局

  • The number of diabetic foot recurrences within one year(one year)
  • Recurrence time(one 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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