AI-Based Diabetic Foot Recurrence Cohort

NCT07452354 | Not Yet Recruiting DMC

• 1 other identifier: Long2026-DFU-Reccurren Cohort
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer (DFU); Diabete Mellitus; Diabetic Foot Ulcer Treatment; Artificial Intelligence (AI) in Diagnosis

Keywords

Diabetic Foot Ulcer; Diabetic Foot Ulcer Treatment; Diabete Mellitus; Reccurrence; Artificial Intelligence (AI) in Diagnosis

Outcome Measures

Primary Outcomes (1)

• One-year recurrence rate of diabetic foot

  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%

  one year

Secondary Outcomes (2)

• The number of diabetic foot recurrences within one year

  one year

• Recurrence time

  one year

Study Arms (1)

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.

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

Interventions

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.

DFU Healed

Eligibility Criteria

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

Study Population

Patient with Diabetic Foot Ulcer have just completely healed

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• [1] Li Y, Teng D, Shi X, et al. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross-sectional study. BMJ. 2020 Apr 28;369:m997. [2] Edmonds M. A renaissance in diabetic foot care: new evidence-based treatments. Lancet Diabetes Endocrinol. 2018;6(11):837-838. [3] Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: a clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016;63(2) (suppl):3S-21S. [4] Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018;1411(1): 153-165. [5] JeffcoateWJ, Vileikyte L, Boyko EJ, Armstrong DG, Boulton AJM. Current challenges and opportunities in the prevention and management of diabetic foot ulcers. Diabetes Care. 2018;41(4):645-652 [6] Aldana PC, Khachemoune A. Diabetic foot ulcers: appraising standard of care and reviewing new trends in management. Am J Clin Dermatol. 2020;21(2):255-264. [7] Bus SA, Van Netten JJ, Hinchliffe RJ, Apelqvist J, Lipsky BA, Schaper NC; IWGDF Editorial Board. Standards for the development and methodology of the 2019 International Working Group on the Diabetic Foot guidelines. Diabetes Metab Res Rev. 2020;36(suppl 1):e3267. [8] Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. [9] Wukich DK, Sambenedetto TL, Mota NM, Suder NC, Rosario BL. Correlation of SF-36 and SF-12 Component Scores in Patients With Diabetic Foot Disease. J Foot Ankle Surg. 2016 Jul-Aug;55(4):693-6. [10] Baltzis D, Eleftheriadou I, Veves A. Pathogenesis and treatment of impaired wound healing in diabetes mellitus: new insights. Adv Ther. 2014;31(8):817-836. [11] Jalilian M, Ahmadi Sarbarzeh P, Oubari S. Factors related to severity of diabetic foot ulcer: a systematic review. Diabetes Metab Syndr

  BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Long Zhang 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: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Wound Healing Center

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

CN (1)