Diabetic Foot Ulcer (DFU)NCT07277010
AI Wound Alert & Home Management for Recurrent DFU
An observational study of Diabetic Foot Ulcer (DFU), run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- Individualized follow-up care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- How long will I take part?
- 1 Year
- 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: The population with DFU recovery
Who may be able to join
- 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.
Who cannot join
- 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.
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: Building an Artificial Intelligence-Driven Early Warning System and Home Management Protocol for a Diabetic Foot Ulcer Recurrence Cohort
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)
- Being tested
- Individualized follow-up care
- Keywords
- diabetic foot ulcer, recurrent, precaution
- Medical subject headings
- Diabetic Foot, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized follow-up careBehavioural
Re-classification system for high-risk feet, along with individualized follow-up care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Individualized follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
Number of patients with Wagner stage 1/2 among those who experienced DFU recurrence within 1 year of follow-up / Total number of patients who experienced DFU recurrence within 1 year of follow-up
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 1 Year
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
- NCT07277010
- Sponsor's protocol ID
- Long2025-DFU-recurrence cohort
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building an Artificial Intelligence-Driven Early Warning System and Home Management Protocol for a Diabetic Foot Ulcer Recurrence Cohort
- ClinicalTrials.gov ID
- NCT07277010
- Acronym / sponsor ID
- Long2025-DFU-recurrence cohort
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- diabetic foot ulcer, recurrent, precaution
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Dec 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The population with DFU recovery | – | Behavioral: Individualized follow-up careThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population with DFU recovery
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Individualized follow-up careRe-classification system for high-risk feet, along with individualized follow-up care | Behavioural | The population with DFU recovery |
Primary outcome
1-year recurrence rate of diabetic foot
Time frame: 1-year
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 secondary outcome
Proportion of patients with Wagner grade 1/2 among those who experienced DFU recurrence within 1 year of follow-up
Time frame: 1-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 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcer (DFU)
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Active, not recruiting
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU)
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), 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 3 inclusion and 2 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 11 Dec 2025. 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 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?
1-year recurrence rate of diabetic foot (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.