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Tele-homecare Service for Diabetic Foot Patients (Risk 0, Risk 1 and Risk 2 Level): Testing and Validation of Dedicated APPs and Artificial Intelligence Solutions

NCT05829811 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-26

No results posted yet for this study

Summary

MY FOOT project aims at filling the gap in mobile applications by providing evidence to both involved stakeholders, that is the remote assistance from the hospital and the patient, who is directly involved in their own care strategy.

In particular, the application has to motivate patients and engage them in their self-care. Interaction with the mobile phone application is in the following terms:

APP elaborates data input from the patient in terms of own feeling of health status, symptoms revealed along the day, events eventually occurred, photos of the foot, including ulcer zoom (if any), APP reports back about increase / decrease in the Risk Level graph through time, maps the ulcer evolution or healing based on photos elaboration, using adequate graphs reporting time in the main axis, whilst reminds personal goals to enact care on a regular basis on the basis of the current conditions, eventually alerts the patient to contact clinicians for a visual inspection at a hospital.

Conditions

  • APP Elaborates Data Input From the Patient With Foot Ulcer

Interventions

DEVICE

Lifestyle APP and Artificial Intelligence solutions validation

The lifestyle APP will take into account all the psychological aspect linked to the disease, including the social isolation. Lifestyle APP is not a measurement technology but it is a preventive measures against diabetes evolution that provide insights and advices daily, by the collection of structured data of parameters, essential to feed the AI for Risk analysis module. The involvement of Physicians expert in this discipline will evaluate the effectiveness of the psychosocial education.

Sponsors & Collaborators

  • Faculty Hospital AGEL Skalica

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-09-01
Completion
2026-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829811 on ClinicalTrials.gov