AI wound alert system and home care for people with repeat diabetic foot ulcers
Builds an AI tool to spot returning diabetic foot ulcers in adults.
Key facts
- Who runs it
- Peking University Third Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- AI-Based Diabetic Foot Recurrence Cohort
- Status
- Not yet recruiting
- People taking part
- 200 people, planned
- Started
- 15 Mar 2026
- Expected to end
- 31 Dec 2028
- Type of study
- Observational
- Treatments tested
- Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.
- Record updated
- 5 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 or type 2 diabetes whose diabetic foot ulcer has fully healed after treatment. It follows them to spot a new ulcer early, using an AI wound alert system and care at home.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- A foot wound caused by diabetes that has fully healed: dry, no fluid, covered by new skin, with no redness or swelling around it, and strong enough to bear pressure without opening.
- Earlier treatment
- The foot ulcer must have been treated and fully healed.
- Biomarker or test result
- Diabetes confirmed by the World Health Organization criteria.
Main reasons for not taking part
- Not able to cooperate
- Having a psychiatric (mental health) disorder
- The study doctor judges the person cannot take part or cannot follow the study rules
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- 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.
Treatment: Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot Recurrence Cohort
- Plain-language title
- AI wound alert system and home care for people with repeat diabetic foot ulcersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 5 March 2026