AI Wound Alert & Home Management for Recurrent DFU

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The population with DFU recovery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Individualized follow-up care

    Behavioral

    Re-classification system for high-risk feet, along with individualized follow-up care

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: The population with DFU recovery1 intervention

Trial outcomes

Primary outcomes

1

1-year recurrence rate of diabetic foot

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%

Time frame
1-year

Secondary outcomes

1

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

Number of patients with Wagner stage 1/2 among those who experienced DFU recurrence within 1 year of follow-up / Total number of patients who experienced DFU recurrence within 1 year of follow-up

Time frame
1-year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: