Not yet recruiting 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 patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Foot Care Control Group, Digital Foot Care (Low-Intensity), Digital Foot Care (Moderate-Intensity).
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcers (DFUs). Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of Diabetic Foot Ulcers [Time frame: 18 months after intervention initiation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07185048 · 2025-302