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Diabetic Foot Ulcers (DFU)NCT06977048

Effects of an Animated Mobile Application on Diabetic Foot Ulcer Management

A study testing Mobile Application-Based Educational Program in people with Diabetic Foot Ulcers (DFU), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study was designed to evaluate the effect of education delivered through an animation-based mobile application on the knowledge level, self-efficacy, wound size, and metabolic parameters of individuals with diabetic foot ulcers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcers (DFU)
What is being tested?
Mobile Application-Based Educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Apr 2025to 25 Dec 2025
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having a diagnosis of diabetic foot ulcer, having stage 1-2 diabetic foot ulcer according to Wagner classification system, being between the ages of 18-65, being literate, having and using a mobile phone with IOS and ANDROID operating system, volunteering to participate in the study

Who cannot join

  • Users who want to withdraw from the research, the patient's exitus during the research process, users who do not log in to the mobile application once a week during the implementation process of the research (twelve weeks) will be excluded from the research.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gülhane Training and Research Hospital, University of Health Sciences, Turkey

    Ankara, Keçiören, 06300

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Education Provided Through an Animation-based Mobile Application on Disease Knowledge, Self-efficacy, Wound Size, and Metabolic Parameters in Patients With Diabetic Foot Ulcers: A Randomized Controlled Trial

This study was designed to evaluate the effect of education delivered through an animation-based mobile application on the knowledge level, self-efficacy, wound size, and metabolic parameters of individuals with diabetic foot ulcers.

Read the detailed description

Diabetic foot is one of the most serious complications of diabetes, negatively affecting not only patients but also caregivers, healthcare professionals, and the broader society, both medically and economically. Peripheral neuropathy, peripheral arterial disease, microvascular and macrovascular alterations, impaired glycemic regulation, recurrent trauma, and inadequate foot care can lead to the development of diabetic foot ulcers (DFUs), which may progress to osteomyelitis. Each year, approximately 18.6 million people worldwide are affected by diabetic foot ulcers. The five-year mortality rate among these individuals is around 30%, and it exceeds 70% in those with a history of major amputation. Primary treatment approaches for DFUs include surgical debridement, offloading, treatment of peripheral arterial disease, and infection management. Additionally, therapies such as hyperbaric oxygen, wound dressings, negative pressure wound therapy, and topical oxygen are also employed in the management of diabetic foot ulcers. Compared to amputations due to other causes, a significant proportion of amputations resulting from DFUs are preventable. For this reason, education on diabetes and foot care has been shown to prevent ulcer formation and subsequently reduce amputation rates and associated morbidity.

Individuals with diabetes need to possess an adequate level of self-efficacy in order to effectively manage lifelong treatment, care, and lifestyle changes. Self-efficacy is defined as a cognitive process through which individuals believe they can influence future outcomes via environmental and social factors and thereby learn new behaviors. It is known that individuals with high self-efficacy are more actively involved in their own care and experience the chronic disease process more successfully. In diabetes management, perceived self-efficacy is considered crucial by researchers and clinicians, as it is associated with adopting a healthy lifestyle, adhering to medication and treatment regimens, and managing stress. Assessing and promoting patients' self-efficacy is a valuable tool in healthcare settings as it enhances motivation for self-care. Supporting patients in this regard may increase life expectancy and help regulate health behaviors. In a study by Bahador et al., a three-month education program for patients with diabetic foot ulcers significantly improved self-efficacy, foot ulcer care rates, and reduced re-ulceration and complication rates. Similarly, Ayaz, Dinçer, and Oğuz (2020) reviewed 26 systematic studies and 8 meta-analyses on the effects of foot care education in diabetic patients and found that such education improved patients' knowledge and behaviors. The authors emphasized the need for long-term educational interventions.

Recent advances in technology and healthcare worldwide have fostered the integration of these two fields and brought mobile health applications to the forefront. Mobile health applications are software tools used via mobile devices such as smartphones or tablets, and they offer advantages over traditional methods. These applications are employed in the management of various chronic diseases including chronic obstructive pulmonary disease (COPD), depression, dementia, and diabetes, particularly for medication adherence, rehabilitation, symptom control, and tracking medical records. In a study by Marquen et al., a mobile application combined with nursing consultation improved foot self-care among individuals with type 2 diabetes. Similarly, Kilic and Karadag developed a Mobile Diabetic Foot Self-Care System for patients with diabetes mellitus, which enhanced patients' knowledge, behaviors, and self-efficacy scores. The use of mobile applications plays a significant role in advancing mobile health technologies, and it is important that such applications are supported by daily messages, videos, and animations.

Animation is a form of educational material that uses visual simulations to present theoretical knowledge in a more accessible format. Through animation videos, key points of a topic can be highlighted to improve patient understanding, allow repeated viewing of the material, and enhance knowledge levels. In a study by Alyami et al., visual animations shown to patients with type 2 diabetes, their caregivers, and healthcare professionals were found to improve patients' perceptions and enhance the effectiveness of diabetes education. Likewise, Maisrikrod et al. developed an animated educational tool aimed at increasing community awareness in tropical regions where melioidosis and diabetes are prevalent. They concluded that such tools can serve as low-cost, adaptable health education materials.

Being tested
Mobile Application-Based Educational Program, Standard care
Keywords
diabetic foot, animation
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Application-Based Educational ProgramOther

    Week 0:

    Participants are informed about the study and trained in the use of the mobile application.

    The mobile app is installed on their smartphones.

    Educational animation videos and modules are watched with the researcher in a predefined order.

    Questions about animations are answered.

    Videos are downloaded to the participant's phone.

    DFU photographs are recorded.

    Weeks 1-12:

    Participants are instructed to use the app regularly between weeks 5-12.

    Video watching days and durations are logged using a tracking form.

    Weekly push notifications remind participants to use the app.

    Weekly phone calls are made to assess engagement using a structured checklist.

    DFU photographs are taken at weeks 8 and 12.

    At week 12, data are collected in person, including:

    DFU size (length × width) with disposable paper ruler

    Metabolic parameters from blood tests

    Wagner-Meggitt classification

    Re-ulceration assessment

  • Standard careOther

    Participants provide consent and receive baseline information.

    DFU photographs are taken at baseline, week 8, and week 12.

    At week 12, the same outcome measures as the intervention group are collected.

    After the study ends, participants are provided with access to the mobile application.

Study groups in NCT06977048
Study groupRoleWhat they receive
Experimental - Mobile Application-Based Education Group (Intervention Group)OtherParticipants receive an educational intervention via a mobile application with animation-based videos and modules on diabetic foot ulcer (DFU) care. The intervention spans 12 weeks and includes initial training and weekly follow-ups.
Receives: Other: Mobile Application-Based Educational Program
No Intervention - Control GroupOtherParticipants in this group receive no educational intervention and continue their usual care.
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Diabetic Foot Ulcer Size (cm²)

    This outcome measures the change in the surface area (cm²) of the diabetic foot ulcer from baseline (Week 0) to the end of the intervention (Week 12). The wound size is calculated using the formula length × width (cm × cm).

    Measured: aseline (Week 0) Follow-up (Week 12) (Optional intermediate check at Week 8)

  2. The Diabetic Foot Care Self-Efficacy Scale (DFCSES)

    The Diabetic Foot Care Self-Efficacy Scale (DFCSES), originally developed by Quarles (2005) and adapted into Turkish by Kır Biçer (2011), will be used to assess participants' self-efficacy regarding diabetic foot care. The scale consists of 9 items rated on a scale from 0 (not confident at all) to 10 (completely confident), with total scores ranging from 0 to 90. Higher scores reflect greater self-efficacy in diabetic foot care. The change in total score from baseline to 12 weeks post-intervention will be evaluated.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  3. Change in Diabetic Foot Knowledge Score

    Knowledge of diabetic foot care will be measured using a 5-item subscale from the Diabetes Knowledge Questionnaire-24 (DKQ-24), originally developed by Garcia et al. and adapted into Turkish by Biçer. Each item is answered as "Yes," "No," or "I don't know." Total scores range from 0 to 5, with higher scores reflecting greater knowledge of diabetic foot care. The change in score from baseline to 12 weeks post-intervention will be assessed.

    Measured: Baseline (Week 0) Follow-up (Week 12)

Secondary outcomes (7)
  1. Change in HbA1c (%)

    HbA1c levels will be measured as part of routine laboratory testing. The change in HbA1c (%) from baseline to 12 weeks after the intervention will be evaluated.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  2. Change in Fasting Blood Glucose (mg/dL)

    Fasting blood glucose (mg/dL) levels will be obtained from routine clinical tests. The change between baseline and 12 weeks post-intervention will be assessed.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  3. Change in Triglycerides (mg/dL)

    Serum triglyceride levels (mg/dL) will be recorded from routine lab results. The change from baseline to 12 weeks will be analyzed.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  4. Change in HDL Cholesterol (mg/dL)

    HDL levels (mg/dL) will be obtained from standard lab testing. The difference between pre- and post-intervention values will be evaluated.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  5. Change in LDL Cholesterol (mg/dL)

    LDL cholesterol levels (mg/dL) will be retrieved from routine blood tests. Change from baseline to follow-up will be measured.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  6. Change in Total Cholesterol (mg/dL)

    Total cholesterol levels (mg/dL) will be taken from regular lab reports. Change from baseline to 12 weeks will be analyzed.

    Measured: Baseline (Week 0) Follow-up (Week 12)

  7. Change in Body Mass Index (BMI, kg/m²)

    BMI will be calculated from measured height and weight. The change in BMI (kg/m²) from baseline to 12 weeks post-intervention will be recorded.

    Measured: Baseline (Week 0) Follow-up (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start30 Apr 2025
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion25 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be divided into intervention and control groups by simple randomisation.
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06977048
Sponsor's protocol ID
SBU-H-MG-06
Status last verified
Apr 2025
First submitted
1 May 2025
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) will not be shared due to ethical concerns and institutional policy restrictions. The collected data include sensitive health information that cannot be anonymized adequately to protect participant privacy.

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Application-Based Educational Program in people with Diabetic Foot Ulcers (DFU), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

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 1 inclusion and 1 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 16 May 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 Turkey (Türkiye). 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?

Change in Diabetic Foot Ulcer Size (cm²) (time frame: aseline (Week 0) Follow-up (Week 12) (Optional intermediate check at Week 8)). The study lists 3 primary outcomes in all. 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 16 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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