Type 2 Diabetes Mellitus (T2DM)NCT07813676
Effect of Digital-Supported Foot Care Education in Individuals With Type 2 Diabetes
A study testing Digital-Supported Foot Care Education in people with Type 2 Diabetes Mellitus (T2DM), run by Siirt University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial will evaluate the effect of digital-supported foot care education on foot care knowledge, self-care behaviors, and self-efficacy in individuals with type 2 diabetes. A total of 90 participants will be randomly assigned to an intervention group (n=45) or a control group (n=45). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Digital-Supported Foot Care Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2026to 31 Jul 2027
- 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
- Diagnosis of type 2 diabetes mellitus according to ICD-10 criteria for at least 6 months.
- Age 18 years or older.
- Stable general health condition.
- No condition that would prevent communication or understanding of the education, including severe cognitive, hearing, or speech impairment.
- Ability to communicate in Turkish and sufficient cognitive ability to understand the education.
- Voluntary participation and provision of written informed consent.
- Ability to access video and visual educational materials via QR codes either independently or with the assistance of a relative/caregiver.
Who cannot join
- Previous participation in a structured diabetic foot care education program.
- Presence of an active diabetic foot ulcer or a history of amputation.
- Presence of a serious neurological or orthopedic condition, other than diabetes-related conditions, that may directly affect foot care.
- Anticipated inability to regularly participate in the planned education and follow-up procedures.
- Presence of an acute complication of diabetes requiring emergency clinical intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Siirt Training and Research Hospital
Siirt, Siirt, 56100
Zeliha Buyukbayram Genç, PhD, +905533931157, zeliha_bbayram@hotmail.com
About this study
Official title: The Effect of Digital-Supported Foot Care Education on Knowledge, Self-Care Behavior, and Self-Efficacy in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effect of digital-supported foot care education on foot care knowledge, self-care behaviors, and self-efficacy in individuals with type 2 diabetes. A total of 90 participants will be randomly assigned to an intervention group (n=45) or a control group (n=45). Participants in the intervention group will receive structured foot care education supported by videos and visual materials accessible through QR codes, together with hands-on training using a diabetic foot model. Participants in the control group will receive standard care. Foot care knowledge, self-care behaviors, and foot care self-efficacy will be assessed before and after the intervention. The study aims to determine whether digital-supported foot care education is effective in improving these outcomes among individuals with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Digital-Supported Foot Care Education
- Keywords
- Type 2 Diabetes, Diabetic Foot, Digital Education, Foot Care Education, Self-Care Behavior, Self-Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-Supported Foot Care EducationBehavioural
Participants will receive two individual face-to-face foot care education sessions, each lasting 20-25 minutes. The education will include practical demonstrations using a diabetic foot model and will be supported by video and visual materials accessible via QR codes. Participants will be encouraged to access the digital materials at least twice a week for four weeks. During this period, regular reminders will be provided via text messages and/or telephone calls to support continued engagement with the educational materials.
| Study group | Role | What they receive |
|---|---|---|
| Digital-Supported Foot Care Education Group | Experimental | Participants assigned to the intervention group will receive two individual face-to-face foot care education sessions, each lasting 20-25 minutes. The education will be supported by QR code-accessible video and visual materials and hands-on demonstrations using a diabetic foot model. Participants will be encouraged to access the digital materials at least twice a week for four weeks and will receive regular reminders via text messages and/or telephone calls. Receives: Behavioral: Digital-Supported Foot Care Education |
| Control Group | No intervention | Participants assigned to the control group will continue to receive routine care and will not receive the digital-supported foot care education during the study period. After completion of the study, the educational materials will be offered to control group participants who wish to receive them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetic Foot Care Knowledge
Diabetic foot care knowledge will be assessed using the Diabetic Foot Knowledge Scale. The scale consists of 5 items, with total scores ranging from 0 to 5. Higher scores indicate a higher level of diabetic foot care knowledge. Change in scores from baseline to the end of the 4-week intervention period will be evaluated.
Measured: Baseline and at the end of Week 4
Change in Diabetic Foot Self-Care Behavior
Diabetic foot self-care behavior will be assessed using the Diabetic Foot Self-Care Behavior Scale. The scale consists of 7 items, with total scores ranging from 7 to 35. Higher scores indicate better diabetic foot self-care behavior. Change in scores from baseline to the end of Week 4 will be evaluated.
Measured: Baseline and at the end of Week 4
Change in Diabetic Foot Care Self-Efficacy
Diabetic foot care self-efficacy will be assessed using the Diabetic Foot Care Self-Efficacy Scale. The scale consists of 9 items rated from 0 (not at all confident) to 10 (very confident). Higher scores indicate greater diabetic foot care self-efficacy. Change in scores from baseline to the end of Week 4 will be evaluated.
Measured: Baseline and at the end of Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Buyukbayram Genç, Siirt University
- Investigators
- Zeliha Büyükbayram Genç, PhD, Principal investigator, Siirt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813676
- Sponsor's protocol ID
- 2026-SİÜSBF-016
- Other IDs
- 2026-SİÜSBF-016
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital-Supported Foot Care Education on Knowledge, Self-Care Behavior, and Self-Efficacy in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07813676
- Acronym / sponsor ID
- 2026-SİÜSBF-016
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Type 2 Diabetes, Diabetic Foot, Digital Education, Foot Care Education, Self-Care Behavior, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Sep 2026 (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 randomized controlled trial will evaluate the effect of digital-supported foot care education on foot care knowledge, self-care behaviors, and self-efficacy in individuals with type 2 diabetes. A total of 90 participants will be randomly assigned to an intervention group (n=45) or a control group (n=45). Participants in the intervention group will receive structured foot care education supported by videos and visual materials accessible through QR codes, together with hands-on training using a diabetic foot model. Participants in the control group will receive standard care. Foot care knowledge, self-care behaviors, and foot care self-efficacy will be assessed before and after the intervention. The study aims to determine whether digital-supported foot care education is effective in improving these outcomes among individuals with type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital-Supported Foot Care Education Group | Experimental | Behavioral: Digital-Supported Foot Care EducationParticipants assigned to the intervention group will receive two individual face-to-face foot care education sessions, each lasting 20-25 minutes. The education will be supported by QR code-accessible video and visual materials and hands-on demonstrations using a diabetic foot model. Participants will be encouraged to access the digital materials at least twice a week for four weeks and will receive regular reminders via text messages and/or telephone calls. |
| Control Group | No intervention | –Participants assigned to the control group will continue to receive routine care and will not receive the digital-supported foot care education during the study period. After completion of the study, the educational materials will be offered to control group participants who wish to receive them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of type 2 diabetes mellitus according to ICD-10 criteria for at least 6 months.
- Age 18 years or older.
- Stable general health condition.
- No condition that would prevent communication or understanding of the education, including severe cognitive, hearing, or speech impairment.
- Ability to communicate in Turkish and sufficient cognitive ability to understand the education.
Key exclusion criteria (5 listed)
- Previous participation in a structured diabetic foot care education program.
- Presence of an active diabetic foot ulcer or a history of amputation.
- Presence of a serious neurological or orthopedic condition, other than diabetes-related conditions, that may directly affect foot care.
- Anticipated inability to regularly participate in the planned education and follow-up procedures.
- Presence of an acute complication of diabetes requiring emergency clinical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital-Supported Foot Care EducationParticipants will receive two individual face-to-face foot care education sessions, each lasting 20-25 minutes. The education will include practical demonstrations using a diabetic foot model and will be supported by video and visual materials accessible via QR codes. Participants will be encouraged to access the digital materials at least twice a week for four weeks. During this period, regular reminders will be provided via text messages and/or telephone calls to support continued engagement with the educational materials. | Behavioural | Digital-Supported Foot Care Education Group |
Primary outcome
Change in Diabetic Foot Care Knowledge
Time frame: Baseline and at the end of Week 4
Diabetic foot care knowledge will be assessed using the Diabetic Foot Knowledge Scale. The scale consists of 5 items, with total scores ranging from 0 to 5. Higher scores indicate a higher level of diabetic foot care knowledge. Change in scores from baseline to the end of the 4-week intervention period will be evaluated.
Change in Diabetic Foot Self-Care Behavior
Time frame: Baseline and at the end of Week 4
Diabetic foot self-care behavior will be assessed using the Diabetic Foot Self-Care Behavior Scale. The scale consists of 7 items, with total scores ranging from 7 to 35. Higher scores indicate better diabetic foot self-care behavior. Change in scores from baseline to the end of Week 4 will be evaluated.
Change in Diabetic Foot Care Self-Efficacy
Time frame: Baseline and at the end of Week 4
Diabetic foot care self-efficacy will be assessed using the Diabetic Foot Care Self-Efficacy Scale. The scale consists of 9 items rated from 0 (not at all confident) to 10 (very confident). Higher scores indicate greater diabetic foot care self-efficacy. Change in scores from baseline to the end of Week 4 will be evaluated.
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Zeliha Büyükbayram Genç, PhD principal investigator
Siirt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital-Supported Foot Care Education in people with Type 2 Diabetes Mellitus (T2DM), run by Siirt University 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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?
Contact Zeliha Büyükbayram Genç, PhD (+905533931157, zeliha_bbayram@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetic Foot Care Knowledge (time frame: Baseline and at the end of Week 4). 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 10 Sep 2026.