NCT07185048

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

Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,512 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
BEHAVIORAL	Conventional Foot Care Control Group	Standard Foot Care with Regular Follow-up
BEHAVIORAL	Digital Foot Care (Low-Intensity)	On the basis of routine management, the digital intervention modules will be added
BEHAVIORAL	Digital Foot Care (Moderate-Intensity)	Further integration of AI image analysis for auxiliary judgment and remote physician response.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-09-22
• Last updated: 2025-09-22