Prevention of Diabetic FootDiabetesNCT07114445
The Effect of Diabetic Foot Training Given to Patients With Type-2 Diabetes Using Virtual Reality Glasses on Foot Care Behaviors
A study testing Diabetes Treatment in people with Prevention of Diabetic Foot, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Diabetes mellitus is a chronic disease characterized by high blood sugar resulting from insulin deficiency and/or ineffectiveness. Diabetes is increasingly recognized as a significant public health problem due to its increasing prevalence and potential for a wide range of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Diabetic Foot
- What is being tested?
- Diabetes Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Dec 2026
- 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
- Patients who were diagnosed with type 2 diabetes at least six months ago
- Those who are over 18 years of age
- Those who volunteer to participate in the study
- Those who can read and write
- Those who have no problems accessing the internet
- Those who have the ability to use a telephone
Show all 9Show fewer
- Those who do not have sensory losses such as vision or hearing
- Those who do not have communication problems or those who do not have a perception or psychiatric disease diagnosis that would prevent communication
- Those who do not have ulceration in the foot and/or ankle area and/or who have not been diagnosed with diabetic foot will be included in the study.
Who cannot join
- Individuals who do not meet the criteria for inclusion in the study will be excluded from the study.
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
Gaziantep Üniversitesi
Gaziantep, Gaziantep, 27000
About this study
Diabetes mellitus is a chronic disease characterized by high blood sugar resulting from insulin deficiency and/or ineffectiveness. Diabetes is increasingly recognized as a significant public health problem due to its increasing prevalence and potential for a wide range of complications. Diabetic foot, one of the most common complications of diabetes, has become a widespread problem in parallel with the rapidly increasing prevalence of diabetes both globally and domestically. Since healthcare expenditures for diabetic foot care account for one-third of total spending on diabetes treatment, the importance of planning patient education, implementing evidence-based preventive approaches, and regularly monitoring patients to prevent the development of diabetes and diabetic foot is evident. Furthermore, the adoption of evidence-based preventive approaches and regular patient follow-up are essential in this context. Diabetes education nurses, in particular, play a critical role in this regard. Today, with advancements in health technologies and diabetes treatments, significant breakthroughs and improvements in diabetes treatment and care are regularly occurring. Therefore, nurses should plan and implement training every six months or even annually to share current information with patients and facilitate their adaptation to new treatment approaches. The literature particularly emphasizes the importance of providing comprehensive education to individuals with diabetes on disease management, including diet, medication, exercise, and foot care. The need to address the specific needs of these patients for optimal care is also emphasized. Therefore, it is crucial to design and implement effective educational strategies that incorporate current technological applications to transform the knowledge and habits of individuals with diabetes into adaptive behaviors that can reduce the likelihood of developing diabetic foot ulcers. One such application, virtual reality headsets, provide an immersive, three-dimensional virtual environment with high-quality visuals and audio, enabling individuals to learn through experiential learning by simulating realistic scenarios. This application can also increase patients' skill proficiency and motivation. However, our review of the relevant literature revealed no studies using virtual reality headsets as a method for providing diabetic foot education. In light of the above, this study, which examines the impact of diabetic foot education provided to patients via virtual reality headsets on foot care behaviors, is expected to be unique compared to similar studies. The research results are expected to contribute significantly to the prevention of diabetic foot ulcers and the provision of optimum diabetic foot care.
Read the detailed description
Developing preventive diabetic foot care practices in a virtual environment and demonstrating them to patients using VR headsets: An educational video prepared in a virtual environment based on literature and expert opinions (the educational content was developed in accordance with the Printable Materials Patient Education Material Assessment Tool (HEMDA-B) by consulting an endocrinologist, a podiatrist, a diabetes education nurse, and nine faculty members from various universities). This video will be integrated into VR headsets and demonstrated to patients. The educational content will cover the importance of diabetes and the diabetic foot, risk factors for the diabetic foot, the causes of diabetic foot and diabetic foot symptoms, preventive foot care behaviors, how to perform a self-foot examination, proper nail care, choosing appropriate socks and shoes, insole requirements for patients diagnosed with diabetes mellitus, when to consult a healthcare professional for foot care, and examples of diabetic foot cases with visual examples. Another important aspect of this study is that no study in the literature has been found where preventive diabetic foot education developed in a virtual environment has been implemented using VR headsets. • The training will be provided five times: at baseline, at 4, 8, 12, and 24 weeks. Since patients will be called to the hospital as part of their routine checkups, it will not create any financial or emotional burden.
- The study will include patients who have not previously experienced diabetic foot ulcers. No training program has been found in the literature for patients diagnosed with type 2 diabetes who wear SG glasses. It is believed that this training, unlike traditional learning methods, will provide patients with the opportunity to learn more actively, through hands-on experience, the importance of foot care, how to perform it, and where they have made mistakes in the past.
- This group was chosen because diabetic foot problems are the only complication of diabetes that can be prevented through education. The education provided leads to significant reductions in wound formation and amputations. Preventing diabetic foot problems through education and simple measures is much easier than treating the problem.
- Conditions
- Prevention of Diabetic Foot
- Being tested
- Diabetes Treatment
- Keywords
- virtual reality, diabetic foot training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes TreatmentOther
Training with virtual reality glasses
| Study group | Role | What they receive |
|---|---|---|
| Virtual Glasses Education Group | Experimental | Patients in the intervention group will be called to the hospital at baseline, weeks 4, 8, 12, and 24 as part of routine checkups based on the educational content developed in line with the literature. The diabetic foot training will be repeated using virtual reality glasses, followed by the foot care behavior scale. Data collection forms will be administered to the patients by the researchers using a face-to-face interview technique, lasting approximately 15-20 minutes. Receives: Other: Diabetes Treatment |
| Kontrol grubu | No intervention | Patients in the control group will not receive any intervention other than the routine practices of the clinic, and data collection tools will be applied when they come to the polyclinic for routine check-ups simultaneously with the intervention group. At the end of the study, patients in the control group will also receive one diabetic foot training with virtual reality glasses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months after giving the first training.The lowest possible score on the Foot Care Behavior Scale (FBS) is 15, and the highest score is 75. A higher scale score indicates that the individual's foot self-care behaviors are better.
Diabetic foot training, developed based on literature and expert opinions, will be delivered to patients in the intervention group using virtual reality goggles. The training will cover the importance of diabetes and diabetic foot, risk factors for diabetic foot, causes and symptoms of diabetic foot, preventive foot care practices, how to perform a self-examination of the foot, proper nail care, appropriate sock and shoe selection, insole needs for patients diagnosed with diabetes mellitus, when to consult a healthcare professional for foot care, and examples of diabetic foot cases with visual examples. Patients in the intervention group will receive the diabetic foot training using virtual reality goggles at baseline, 4, 8, 12, and 24 weeks, and will then be administered the Diabetic Foot Behavior Scale. The program will last approximately six months.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before the study, patients will be informed and their consent will be obtained. After dividing the patients into intervention and control groups, the researcher will administer data collection forms (questionnaire and Foot Care Behavior Scale (FBS) to both groups before the training. Patients in the intervention group will receive preventive diabetic foot training using virtual reality goggles. Patients in the intervention group will be invited to the hospital at baseline, 4th, 8th, 12th, and 24th weeks. Training will be repeated using virtual reality goggles each week, after which the FBS (Foot Care Behavior Scale) will be administered. The 5-point Likert-type scale adapted for the Foot Care Behavior Scale (FBS) consists of a single dimension and 15 items (1= Never, 2= Occasionally, 3= Sometimes, 4= Often, and 5= Always). The lowest possible score on the scale is 15, and the highest is 75. Higher scale scores indicate better foot self-care behaviors.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ILGUN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114445
- Sponsor's protocol ID
- GAZİANTEP U
- Acronym
- Diabetes
- Status last verified
- Aug 2025
- First submitted
- 28 May 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the study will be kept by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetic Foot Training Given to Patients With Type-2 Diabetes Using Virtual Reality Glasses on Foot Care Behaviors
- ClinicalTrials.gov ID
- NCT07114445
- Acronym / sponsor ID
- Diabetes / GAZİANTEP U
- Conditions
- Prevention of Diabetic Foot
- Keywords
- virtual reality, diabetic foot training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 11 Aug 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.
Diabetes mellitus is a chronic disease characterized by high blood sugar resulting from insulin deficiency and/or ineffectiveness. Diabetes is increasingly recognized as a significant public health problem due to its increasing prevalence and potential for a wide range of complications. Diabetic foot, one of the most common complications of diabetes, has become a widespread problem in parallel with the rapidly increasing prevalence of diabetes both globally and domestically. Since healthcare expenditures for diabetic foot care account for one-third of total spending on diabetes treatment, the importance of planning patient education, implementing evidence-based preventive approaches, and regularly monitoring patients to prevent the development of diabetes and diabetic foot is evident. Furthermore, the adoption of evidence-based preventive approaches and regular patient follow-up are essential in this context. Diabetes education nurses, in particular, play a critical role in this regard. Today, with advancements in health technologies and diabetes treatments, significant breakthroughs and improvements in diabetes treatment and care are regularly occurring. Therefore, nurses should plan and implement training every six months or even annually to share current information with patients and facilitate their adaptation to new treatment approaches. The literature particularly emphasizes the importance of providing comprehensive education to individuals with diabetes on disease management, including diet, medication, exercise, and foot care. The need to address the specific needs of these patients for optimal care is also emphasized. Therefore, it is crucial to design and implement effective educational strategies that incorporate current technological applications to transform the knowledge and habits of individuals with diabetes into adaptive behaviors that can reduce the likelihood of developing diabetic foot ulcers. One such application, virtual reality headsets, provide an immersive, three-dimensional virtual environment with high-quality visuals and audio, enabling individuals to learn through experiential learning by simulating realistic scenarios. This application can also increase patients' skill proficiency and motivation. However, our review of the relevant literature revealed no studies using virtual reality headsets as a method for providing diabetic foot education. In light of the above, this study, which examines the impact of diabetic foot education provided to patients via virtual reality headsets on foot care behaviors, is expected to be unique compared to similar studies. The research results are expected to contribute significantly to the prevention of diabetic foot ulcers and the provision of optimum diabetic foot care.
Detailed description
Developing preventive diabetic foot care practices in a virtual environment and demonstrating them to patients using VR headsets: An educational video prepared in a virtual environment based on literature and expert opinions (the educational content was developed in accordance with the Printable Materials Patient Education Material Assessment Tool (HEMDA-B) by consulting an endocrinologist, a podiatrist, a diabetes education nurse, and nine faculty members from various universities). This video will be integrated into VR headsets and demonstrated to patients. The educational content will cover the importance of diabetes and the diabetic foot, risk factors for the diabetic foot, the causes of diabetic foot and diabetic foot symptoms, preventive foot care behaviors, how to perform a self-foot examination, proper nail care, choosing appropriate socks and shoes, insole requirements for patients diagnosed with diabetes mellitus, when to consult a healthcare professional for foot care, and examples of diabetic foot cases with visual examples. Another important aspect of this study is that no study in the literature has been found where preventive diabetic foot education developed in a virtual environment has been implemented using VR headsets. • The training will be provided five times: at baseline, at 4, 8, 12, and 24 weeks. Since patients will be called to the hospital as part of their routine checkups, it will not create any financial or emotional burden.
- The study will include patients who have not previously experienced diabetic foot ulcers. No training program has been found in the literature for patients diagnosed with type 2 diabetes who wear SG glasses. It is believed that this training, unlike traditional learning methods, will provide patients with the opportunity to learn more actively, through hands-on experience, the importance of foot care, how to perform it, and where they have made mistakes in the past.
- This group was chosen because diabetic foot problems are the only complication of diabetes that can be prevented through education. The education provided leads to significant reductions in wound formation and amputations. Preventing diabetic foot problems through education and simple measures is much easier than treating the problem.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before the study, patients will be informed and their consent will be obtained. After dividing the patients into intervention and control groups, the researcher will administer data collection forms (questionnaire and Foot Care Behavior Scale (FBS) to both groups before the training. Patients in the intervention group will receive preventive diabetic foot training using virtual reality goggles. Patients in the intervention group will be invited to the hospital at baseline, 4th, 8th, 12th, and 24th weeks. Training will be repeated using virtual reality goggles each week, after which the FBS (Foot Care Behavior Scale) will be administered. The 5-point Likert-type scale adapted for the Foot Care Behavior Scale (FBS) consists of a single dimension and 15 items (1= Never, 2= Occasionally, 3= Sometimes, 4= Often, and 5= Always). The lowest possible score on the scale is 15, and the highest is 75. Higher scale scores indicate better foot self-care behaviors.
| Arm | Type | Receives |
|---|---|---|
| Virtual Glasses Education Group | Experimental | Other: Diabetes TreatmentPatients in the intervention group will be called to the hospital at baseline, weeks 4, 8, 12, and 24 as part of routine checkups based on the educational content developed in line with the literature. The diabetic foot training will be repeated using virtual reality glasses, followed by the foot care behavior scale. Data collection forms will be administered to the patients by the researchers using a face-to-face interview technique, lasting approximately 15-20 minutes. |
| Kontrol grubu | No intervention | –Patients in the control group will not receive any intervention other than the routine practices of the clinic, and data collection tools will be applied when they come to the polyclinic for routine check-ups simultaneously with the intervention group. At the end of the study, patients in the control group will also receive one diabetic foot training with virtual reality glasses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who were diagnosed with type 2 diabetes at least six months ago
- Those who are over 18 years of age
- Those who volunteer to participate in the study
- Those who can read and write
- Those who have no problems accessing the internet
Key exclusion criteria (1 listed)
- Individuals who do not meet the criteria for inclusion in the study will be excluded from the study.
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 |
|---|---|---|
| Diabetes TreatmentTraining with virtual reality glasses | Other | Virtual Glasses Education Group |
Primary outcome
6 months after giving the first training.The lowest possible score on the Foot Care Behavior Scale (FBS) is 15, and the highest score is 75. A higher scale score indicates that the individual's foot self-care behaviors are better.
Time frame: Six months
Diabetic foot training, developed based on literature and expert opinions, will be delivered to patients in the intervention group using virtual reality goggles. The training will cover the importance of diabetes and diabetic foot, risk factors for diabetic foot, causes and symptoms of diabetic foot, preventive foot care practices, how to perform a self-examination of the foot, proper nail care, appropriate sock and shoe selection, insole needs for patients diagnosed with diabetes mellitus, when to consult a healthcare professional for foot care, and examples of diabetic foot cases with visual examples. Patients in the intervention group will receive the diabetic foot training using virtual reality goggles at baseline, 4, 8, 12, and 24 weeks, and will then be administered the Diabetic Foot Behavior Scale. The program will last approximately six months.
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 14 Aug 2025.
- Individual participant dataSharing planned: No. The data of the study will be kept by the researchers.
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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.
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?
A study testing Diabetes Treatment in people with Prevention of Diabetic Foot, run by University of Gaziantep 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 9 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: enrolling by invitation, as of the sponsor's last update on 14 Aug 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?
6 months after giving the first training.The lowest possible score on the Foot Care Behavior Scale (FBS) is 15, and the highest score is 75. A higher scale score indicates that the individual's foot self-care behaviors are better. (time frame: Six 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 14 Aug 2025.