NCT06844955

Brief Summary

This study developed an app for the guidance of home-based diabetic foot care to explore its impact on patients' foot assessment awareness and self-care behavior after using this app. The study also assessed the app's effectiveness in cultivating behavioral habits that are effective in managing diabetes.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

February 11, 2025

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Foot ulcers

    This study collest Vital signs data and used questionnaires to collect data on whether patients had certain types of chronic diseases, whether they exercised regularly, and on medication use. In addition to diabetes, other chronic conditions, including hypertension, respiratory diseases, heart disease, urinary system disorders, immune system diseases, and hyperlipidemia, were also considered. The study took chronic diseases, exercise, and medication as independent variables. Logistic regression analysis of the association and risk estimation for foot ulcers

    3 months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collect diabetes cases from a Christian hospital in the northeast that agrees to join this program

You may qualify if:

  • Clinical diagnosis of type 2 diabetes .
  • Aged between 20 and 80 years.
  • Able to use mobile apps or tablets for health management .

You may not qualify if:

  • Patients who were unconscious, had delirium, were bedridden, had cognitive impairment, or were unable to perform daily self-care.
  • Patients who refused to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei university of nursing and health science

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vital signs measurement data

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 25, 2025

Study Start

June 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations