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

NCT07185048 | Not Yet Recruiting

• 1 other identifier: 2025-302
• Study Type: interventional
• Target: 1,512
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Incidence of Diabetic Foot Ulcers

  18 months after intervention initiation

Study Arms (3)

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)

Interventions

Conventional Foot Care Control Group BEHAVIORAL

Standard Foot Care with Regular Follow-up

Conventional Foot Care Control Group

Digital Foot Care (Low-Intensity) BEHAVIORAL

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

Low-Intensity Digital Foot Care Group

Digital Foot Care (Moderate-Intensity) BEHAVIORAL

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

Moderate-Intensity Digital Foot Care Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Other conditions deemed inappropriate for participation in this study by the research team.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share