Diabetic Foot Ulcer (DFU)NCT07452354
AI-Based Diabetic Foot Recurrence Cohort
An observational study of Diabetic Foot Ulcer (DFU) and Diabete Mellitus, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Diabete Mellitus, Diabetic Foot Ulcer Treatment
- What is being tested?
- Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Diabetic Foot Ulcer have just completely healed
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yunfeng Li, Medical Doctor, +86 010-82267791, liyunfeng1106@163.com
About this study
Official title: Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a 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.
- Conditions
- Diabetic Foot Ulcer (DFU), Diabete Mellitus, Diabetic Foot Ulcer Treatment, Artificial Intelligence (AI) in Diagnosis
- Being tested
- Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.
- Keywords
- Diabetic Foot Ulcer, Diabetic Foot Ulcer Treatment, Diabete Mellitus, Reccurrence, Artificial Intelligence (AI) in Diagnosis
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: one year
Secondary outcomes (2)
The number of diabetic foot recurrences within one year
The number of diabetic foot recurrences within one year
Measured: one year
Recurrence time
The time from wound healing to the first DFU recurrence
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452354
- Sponsor's protocol ID
- Long2026-DFU-Reccurren Cohort
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
[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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot Recurrence Cohort
- ClinicalTrials.gov ID
- NCT07452354
- Acronym / sponsor ID
- Long2026-DFU-Reccurren Cohort
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFU Healed | – | Diagnostic Test: Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Diabetic Foot Ulcer have just completely healed
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Researchers predefined groups based on risk stratification to formulate personalized follow-up strategies.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. | Diagnostic test | DFU Healed |
Primary outcome
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%
2 secondary outcomes
The number of diabetic foot recurrences within one year
Time frame: one year
Recurrence time
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background[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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer (DFU) and Diabete Mellitus, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Zhang Executive Deputy Director, Medical Doctor (+86 010-82266699, liyunfeng1106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year recurrence rate of diabetic foot (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.