Diabetic Foot Ulcers (DFUs)
Conditions
Brief 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.
Interventions
BEHAVIORALConventional Foot Care Control Group
Standard Foot Care with Regular Follow-up
BEHAVIORALDigital Foot Care (Low-Intensity)
On the basis of routine management, the digital intervention modules will be added
BEHAVIORALDigital Foot Care (Moderate-Intensity)
Further integration of AI image analysis for auxiliary judgment and remote physician response.
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 50 years but \< 80 years; 2. 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); 3. Capable of using a smartphone to take photos and operate apps, or able to do so after simple training; 4. Willing to participate in the study and sign an informed consent form.
Exclusion criteria
1. Currently has an open foot wound or an unresolved foot ulcer; 2. History of major lower limb amputation above the ankle joint; 3. Pregnancy or breastfeeding; 4. Currently suffering from poorly controlled malignant tumors; 5. Receiving glucocorticoid or immunosuppressive therapy; 6. Diagnosed with vascular occlusive vasculitis; 7. Presence of foot fracture; 8. Significant visual impairment affecting image acquisition or operation; 9. Other conditions deemed inappropriate for participation in this study by the research team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Diabetic Foot Ulcers | 18 months after intervention initiation |
Outcome results
None listed