Diabetic Foot Ulcers (DFUs)NCT07185048
Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.
A study testing Digital Foot Care (Low-Intensity) and Digital Foot Care (Moderate-Intensity) in people with Diabetic Foot Ulcers (DFUs), run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcers (DFUs)
- What is being tested?
- Digital Foot Care (Low-Intensity) and Digital Foot Care (Moderate-Intensity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,512 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Sep 2028
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years but < 80 years;
- Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3);
- Capable of using a smartphone to take photos and operate apps, or able to do so after simple training;
- Willing to participate in the study and sign an informed consent form.
Who cannot join
- Currently has an open foot wound or an unresolved foot ulcer;
- History of major lower limb amputation above the ankle joint;
- Pregnancy or breastfeeding;
- Currently suffering from poorly controlled malignant tumors;
- Receiving glucocorticoid or immunosuppressive therapy;
- Diagnosed with vascular occlusive vasculitis;
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- Presence of foot fracture;
- Significant visual impairment affecting image acquisition or operation;
- Other conditions deemed inappropriate for participation in this study by the research team.
About this study
Official title: Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention
For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Being tested
- Conventional Foot Care Control Group, Digital Foot Care (Low-Intensity), Digital Foot Care (Moderate-Intensity)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Foot Care Control GroupBehavioural
Standard Foot Care with Regular Follow-up
Digital Foot Care (Low-Intensity)Behavioural
On the basis of routine management, the digital intervention modules will be added
Digital Foot Care (Moderate-Intensity)Behavioural
Further integration of AI image analysis for auxiliary judgment and remote physician response.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Foot Care Control Group | Active comparator | Not described Receives: Behavioral: Conventional Foot Care Control Group |
| Low-Intensity Digital Foot Care Group | Experimental | Not described Receives: Behavioral: Digital Foot Care (Low-Intensity) |
| Moderate-Intensity Digital Foot Care Group | Experimental | Not described Receives: Behavioral: Digital Foot Care (Moderate-Intensity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Diabetic Foot Ulcers
Measured: 18 months after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 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 Ulcers (DFUs)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,512 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185048
- Sponsor's protocol ID
- 2025-302
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention
- ClinicalTrials.gov ID
- NCT07185048
- Acronym / sponsor ID
- 2025-302
- Conditions
- Diabetic Foot Ulcers (DFUs)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,512 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Sep 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.
For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Foot Care Control Group | Active comparator | Behavioral: Conventional Foot Care Control Group |
| Low-Intensity Digital Foot Care Group | Experimental | Behavioral: Digital Foot Care (Low-Intensity) |
| Moderate-Intensity Digital Foot Care Group | Experimental | Behavioral: Digital Foot Care (Moderate-Intensity) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years but < 80 years;
- Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3);
- Capable of using a smartphone to take photos and operate apps, or able to do so after simple training;
- Willing to participate in the study and sign an informed consent form.
Key exclusion criteria (9 listed)
- Currently has an open foot wound or an unresolved foot ulcer;
- History of major lower limb amputation above the ankle joint;
- Pregnancy or breastfeeding;
- Currently suffering from poorly controlled malignant tumors;
- Receiving glucocorticoid or immunosuppressive therapy;
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 |
|---|---|---|
| Conventional Foot Care Control GroupStandard Foot Care with Regular Follow-up | Behavioural | Conventional Foot Care Control Group |
| Digital Foot Care (Low-Intensity)On the basis of routine management, the digital intervention modules will be added | Behavioural | Low-Intensity Digital Foot Care Group |
| Digital Foot Care (Moderate-Intensity)Further integration of AI image analysis for auxiliary judgment and remote physician response. | Behavioural | Moderate-Intensity Digital Foot Care Group |
Primary outcome
Incidence of Diabetic Foot Ulcers
Time frame: 18 months after intervention initiation
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Foot Care (Low-Intensity) and Digital Foot Care (Moderate-Intensity) in people with Diabetic Foot Ulcers (DFUs), run by First Affiliated Hospital of Wenzhou Medical University.
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 4 inclusion and 9 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Diabetic Foot Ulcers (time frame: 18 months after intervention initiation). 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 22 Sep 2025.