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

NCT ID: NCT07185048

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-09-30

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.

Conditions

Diabetic Foot Ulcers (DFUs)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional Foot Care Control Group

Group Type: ACTIVE_COMPARATOR

Conventional Foot Care Control Group

Intervention Type: BEHAVIORAL

Standard Foot Care with Regular Follow-up

Low-Intensity Digital Foot Care Group

Group Type: EXPERIMENTAL

Digital Foot Care (Low-Intensity)

Intervention Type: BEHAVIORAL

On the basis of routine management, the digital intervention modules will be added

Moderate-Intensity Digital Foot Care Group

Group Type: EXPERIMENTAL

Digital Foot Care (Moderate-Intensity)

Intervention Type: BEHAVIORAL

Further integration of AI image analysis for auxiliary judgment and remote physician response.

Interventions

Conventional Foot Care Control Group

Standard Foot Care with Regular Follow-up

Intervention Type: BEHAVIORAL

Digital Foot Care (Low-Intensity)

On the basis of routine management, the digital intervention modules will be added

Intervention Type: BEHAVIORAL

Digital Foot Care (Moderate-Intensity)

Further integration of AI image analysis for auxiliary judgment and remote physician response.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-302

Identifier Type: -

Identifier Source: org_study_id