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NCT Number: NCT07452354

AI-Based Diabetic Foot Recurrence Cohort

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.

Diagnostic Test

Management strategies encompass follow-up frequency, AI-assisted foot self-examination, AI-powered glucose monitoring, offloading device utilization, daily step count restriction, patient health education, and compliance assessment.

Primary outcomes

  1. One-year recurrence rate of diabetic foot

    Time frame: 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%

Secondary outcomes

  1. The number of diabetic foot recurrences within one year

    Time frame: one year

    The number of diabetic foot recurrences within one year

  2. Recurrence time

    Time frame: one year

    The time from wound healing to the first DFU recurrence

Study contacts

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

Long Zhang 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

Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot Recurrence Cohort

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

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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