Not Yet RecruitingNot Applicable

Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.

1,512 participantsStarted 2025-10

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕. Presence of foot fracture;
✕. Significant visual impairment affecting image acquisition or operation;

What they're measuring

Incidence of Diabetic Foot Ulcers

Timeframe: 18 months after intervention initiation

Trial details

NCT IDNCT07185048

SponsorFirst Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

View on ClinicalTrials.gov More Diabetic Foot Ulcers (DFUs) trials