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NCT Number: NCT07185048

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

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.

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Key information

Conditions

Diabetic Foot Ulcers (DFUs) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Foot Care Control Group

Behavioral

Standard Foot Care with Regular Follow-up

Digital Foot Care (Low-Intensity)

Behavioral

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

Digital Foot Care (Moderate-Intensity)

Behavioral

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

Primary outcomes

  1. Incidence of Diabetic Foot Ulcers

    Time frame: 18 months after intervention initiation

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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