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NCT Number: NCT07277010

AI Wound Alert & Home Management for Recurrent DFU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Individualized follow-up care

Behavioral

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

Primary outcomes

  1. 1-year recurrence rate of diabetic foot

    Time frame: 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%

Secondary outcomes

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

    Time frame: 1-year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Long Executive Deputy Director, Medical Doctor

CONTACT

[email protected]

+86 010-82266699

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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