AI Wound Alert & Home Management for Recurrent DFU

NCT07277010 | Not Yet Recruiting DMC

• 1 other identifier: Long2025-DFU-recurrence cohort
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

diabetic foot ulcer; recurrent; precaution

Outcome Measures

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%

  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

  1-year

Study Arms (1)

The population with DFU recovery

The wound was caused by diabetic foot. After treatment, the wound healed. The healing criteria 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

Behavioral: Individualized follow-up care

Interventions

Individualized follow-up care BEHAVIORAL

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

The population with DFU recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population with DFU recovery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Diabetic Foot; Recurrence

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Long Executive Deputy Director, Medical Doctor

CONTACT

+86 010-82266699; liyunfeng1106@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Wound Healing Center

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

CN (1)