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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,512 Participants
are divided into 3 treatment groups
Group A: Conventional Foot Care Control GroupActive comparator 1 intervention
Group B: Low-Intensity Digital Foot Care GroupExperimental treatment 1 intervention
Group C: Moderate-Intensity Digital Foot Care GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Diabetic Foot Ulcers

Time frame
18 months after intervention initiation

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: