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

Wenzhou Medical University

Status: Not yet enrolling

Conditions: Diabetic Foot Ulcers (DFUs)

Treatments: Behavioral: Digital Foot Care (Low-Intensity); Behavioral: Conventional Foot Care Control Group; Behavioral: Digital Foot Care (Moderate-Intensity)

Study type: Interventional

Funder types: Other

Identifiers

NCT07185048

2025-302

Details and patient eligibility

About

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.

Enrollment: 1,512 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,512 participants in 3 patient groups

Conventional Foot Care Control Group

Active Comparator group

Treatment:

Behavioral: Conventional Foot Care Control Group

Low-Intensity Digital Foot Care Group

Experimental group

Treatment:

Behavioral: Digital Foot Care (Low-Intensity)

Moderate-Intensity Digital Foot Care Group

Experimental group

Treatment:

Behavioral: Digital Foot Care (Moderate-Intensity)