Diabetic FootNTUNHSNCT06844955
Smart Diabetic Foot Care Application
An observational study of Diabetic Foot, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Foot
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2023to 30 Jun 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Collect diabetes cases from a Christian hospital in the northeast that agrees to join this program
Who may be able to join
- Clinical diagnosis of type 2 diabetes .
- Aged between 20 and 80 years.
- Able to use mobile apps or tablets for health management .
Who cannot join
- Patients who were unconscious, had delirium, were bedridden, had cognitive impairment, or were unable to perform daily self-care.
- Patients who refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Using a Smart Diabetic Foot Care Application on Patients' Knowledge and Self-management
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.
Read the detailed description
Diabetes is a common chronic metabolic disease worldwide. Approximately 50% to 60% of ulcers caused by diabetes become infected, and moderate to severe infections can lead to lower limb amputation. Among amputees, the five-year mortality rate exceeds 70%.Smart devices (mobile phones, computers, etc.) are indispensable necessities to modern lives. Downloadable mobile health applications (mHealth Apps) on smartphones are widely used in medical care . The use of these apps on smartphones has created a new field in the health industry known as mobile health
- Conditions
- Diabetic Foot
- Medical subject headings
- Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844955
- Sponsor's protocol ID
- 112-058B
- Acronym
- NTUNHS
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using a Smart Diabetic Foot Care Application on Patients' Knowledge and Self-management
- ClinicalTrials.gov ID
- NCT06844955
- Acronym / sponsor ID
- NTUNHS / 112-058B
- Conditions
- Diabetic Foot
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes is a common chronic metabolic disease worldwide. Approximately 50% to 60% of ulcers caused by diabetes become infected, and moderate to severe infections can lead to lower limb amputation. Among amputees, the five-year mortality rate exceeds 70%.Smart devices (mobile phones, computers, etc.) are indispensable necessities to modern lives. Downloadable mobile health applications (mHealth Apps) on smartphones are widely used in medical care . The use of these apps on smartphones has created a new field in the health industry known as mobile health
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Collect diabetes cases from a Christian hospital in the northeast that agrees to join this program
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 diabetes .
- Aged between 20 and 80 years.
- Able to use mobile apps or tablets for health management .
Key exclusion criteria (2 listed)
- Patients who were unconscious, had delirium, were bedridden, had cognitive impairment, or were unable to perform daily self-care.
- Patients who refused to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Foot ulcers
Time frame: 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot ulcers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.