Diabetic Foot - Telemedical MonitoringNCT07473050
Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes
A study testing "Health for My Feet" virtual reality program. in people with Diabetic Foot - Telemedical Monitoring and Diabetic, run by Ege University.
Trial summary
This randomized controlled experimental study aims to develop and evaluate the effectiveness of a Virtual Reality-Based "Health to My Foot" program designed for individuals with Type II Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Foot - Telemedical Monitoring, Diabetic, Foot Care
- What is being tested?
- "Health for My Feet" virtual reality program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2026to 30 Jul 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Having been diagnosed with type 2 diabetes for at least one year
- Having a risk level of 0, 1, or 2 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification
- Having completed primary education or higher
- Not having hearing, speech, or visual impairments
- Being able to use a smartphone
- Not having received prior training in diabetic foot care
- Being willing to participate in the study
Who cannot join
- Having previously had a diabetic foot ulcer or currently having a diabetic foot ulcer
- Risk level 3 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification
- Having a severe/uncontrolled comorbid disease
- Wishing to withdraw from the study
About this study
Official title: Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes: A Randomized Controlled Study
This randomized controlled experimental study aims to develop and evaluate the effectiveness of a Virtual Reality-Based "Health to My Foot" program designed for individuals with Type II Diabetes Mellitus. The study will assess the program's impact on diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health outcomes.
The research will be conducted between April and October 2026 at a university hospital diabetes outpatient clinic in İzmir, Türkiye. A total of 70 participants diagnosed with Type II DM will be enrolled and randomly assigned to either the intervention group (n=35) or the control group (n=35) using stratified block randomization.
Read more
Participants in the intervention group will receive the Virtual Reality-Based "Health to My Foot" program through virtual reality goggles and will have access to a recorded foot care training video for home use. They will also receive weekly motivational reminder messages for three months. The control group will receive standard outpatient care only.
Data will be collected at baseline (pre-test), 1 month (post-test), and 3 months (follow-up) using validated scales and a nurse follow-up form to evaluate knowledge, self-efficacy, behaviors, and clinical foot health indicators. The findings are expected to contribute to sustainable patient education strategies and to support the prevention of diabetic foot complications and reduction of healthcare costs.
Read the detailed description
The goal of this study: To develop a Virtual Reality-Based "Health to My Foot" program for individuals with Type II DM and to evaluate the effect of the program on individuals' diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health.
Study type: A randomized controlled experimental study The question of this study: Does the Virtual Reality-Based "Health to My Foot" program have an effect on the Diabetic Foot Knowledge, Diabetic Foot Care Self-Efficacy, Foot Care Behavior, and Foot Health of Individuals with Type II Diabetes?
The hypotheses of this study:
Hypothesis 1. H1: The increase in Diabetic Foot Knowledge Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.
Hypothesis 2. H1: The increase in Diabetic Foot Care Self-Efficacy Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.
Hypothesis 3. H1: The increase in Foot Care Behavior Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.
Hypothesis 4. H1: The Diabetic Foot Health Nurse Follow-up examination data (skin condition, sensory findings, etc.) and risk classification status (low risk, medium risk, high risk) of individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied are statistically significantly more positive compared to the control group.
Study Design: The study will be conducted between April-October 2026 at the Diabetes Outpatient Clinic of the Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Ege University Health Application and Research Center in İzmir, Türkiye.
Participants: The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine the number of patients to be included in the research sample. The power analysis was performed using GPower V 3.1.9.4. In line with the information obtained from studies in the literature, a repeated measures approach was used. Accordingly, for an effect size of f = 0.30, with α = 0.05 error and 80% power, the minimum total sample size required in two groups was calculated as 62 (with a minimum of 31 patients in each group). Considering group homogeneity and possible patient losses, the study is planned to be conducted with a total of 70 patients (experimental: 35, control: 35).
Randomization will be performed to ensure homogeneous distribution of the study groups. For this purpose, a stratified block randomization method will be used in terms of age, gender, and the pre-test mean score of the Foot Care Behavior Scale. Participants will be stratified according to age (18-45 / 46-65+), gender (female/male), and Foot Care Behavior Scale pre-test score (≥45 / <45).
To ensure allocation concealment, the "Sequentially Numbered, Opaque, Sealed Envelopes" (SNOSE) method will be used. The randomization schedule will be created via computer software by an independent person not directly involved in the study, and the sealed envelopes prepared according to this schedule will be opened sequentially after the participant is included in the study and the pre-test assessment is completed. Thus, the researcher's prior knowledge of which group (intervention or control) the next participant will be assigned to and the creation of selection bias will be prevented.
In the study, blinding cannot be performed because the researchers will know the groups in which the individuals are included. However, blinding will be applied in data analysis to minimize measurement bias. In the dataset, the groups will be coded as "Group A" and "Group B" and analyzed by an independent biostatistics expert who does not know which group received the intervention.
The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine
- Being tested
- "Health for My Feet" virtual reality program.
- Keywords
- Diabetic foot, Foot care, Virtual Reality, nursing, nursing care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Health for My Feet" virtual reality program.Behavioural
In addition to their routine treatment and monitoring, individuals in this group will be included in the "Health for My Feet" virtual reality program.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will not receive any intervention and will receive their routine care and treatment. |
| Study | Experimental | This group will receive VR-based intervention and will receive their routine care and treatment. Receives: Behavioral: "Health for My Feet" virtual reality program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score of the Diabetic Foot Knowledge Scale
The outcome is the change in the total score of the Diabetic Foot Knowledge Scale (DFKS). The scale assesses participants' knowledge regarding diabetic foot care. Scores are calculated by summing item responses, with higher scores indicating greater knowledge. The change in total score will be calculated by comparing baseline (pre-test), 1-month post-intervention, and 3-month follow-up assessments.
Measured: Baseline, 1 month post-intervention, and 3 months follow-up
Secondary outcomes (1)
Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form
Change in the total score of the Diabetic Foot Health Nurse Follow-up Form between baseline and 3 months. The form evaluates clinical foot health through nurse assessment of several domains including skin integrity, presence of lesions, sensory status, and nail condition. Scores are calculated by summing the item scores, with higher scores indicating poorer foot health status.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Apr 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot - Telemedical MonitoringStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı KALKIM, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473050
- Sponsor's protocol ID
- 26-2.1T/32
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 16 Mar 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07473050
- Acronym / sponsor ID
- 26-2.1T/32
- Keywords
- Diabetic foot, Foot care, Virtual Reality, nursing, nursing care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 16 Mar 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 experimental study aims to develop and evaluate the effectiveness of a Virtual Reality-Based "Health to My Foot" program designed for individuals with Type II Diabetes Mellitus. The study will assess the program's impact on diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health outcomes.
The research will be conducted between April and October 2026 at a university hospital diabetes outpatient clinic in İzmir, Türkiye. A total of 70 participants diagnosed with Type II DM will be enrolled and randomly assigned to either the intervention group (n=35) or the control group (n=35) using stratified block randomization.
Participants in the intervention group will receive the Virtual Reality-Based "Health to My Foot" program through virtual reality goggles and will have access to a recorded foot care training video for home use. They will also receive weekly motivational reminder messages for three months. The control group will receive standard outpatient care only.
Data will be collected at baseline (pre-test), 1 month (post-test), and 3 months (follow-up) using validated scales and a nurse follow-up form to evaluate knowledge, self-efficacy, behaviors, and clinical foot health indicators. The findings are expected to contribute to sustainable patient education strategies and to support the prevention of diabetic foot complications and reduction of healthcare costs.
Detailed description
The goal of this study: To develop a Virtual Reality-Based "Health to My Foot" program for individuals with Type II DM and to evaluate the effect of the program on individuals' diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health.
Study type: A randomized controlled experimental study The question of this study: Does the Virtual Reality-Based "Health to My Foot" program have an effect on the Diabetic Foot Knowledge, Diabetic Foot Care Self-Efficacy, Foot Care Behavior, and Foot Health of Individuals with Type II Diabetes?
The hypotheses of this study:
Hypothesis 1. H1: The increase in Diabetic Foot Knowledge Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.
Hypothesis 2. H1: The increase in Diabetic Foot Care Self-Efficacy Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.
Hypothesis 3. H1: The increase in Foot Care Behavior Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.
Hypothesis 4. H1: The Diabetic Foot Health Nurse Follow-up examination data (skin condition, sensory findings, etc.) and risk classification status (low risk, medium risk, high risk) of individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied are statistically significantly more positive compared to the control group.
Study Design: The study will be conducted between April-October 2026 at the Diabetes Outpatient Clinic of the Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Ege University Health Application and Research Center in İzmir, Türkiye.
Participants: The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine the number of patients to be included in the research sample. The power analysis was performed using GPower V 3.1.9.4. In line with the information obtained from studies in the literature, a repeated measures approach was used. Accordingly, for an effect size of f = 0.30, with α = 0.05 error and 80% power, the minimum total sample size required in two groups was calculated as 62 (with a minimum of 31 patients in each group). Considering group homogeneity and possible patient losses, the study is planned to be conducted with a total of 70 patients (experimental: 35, control: 35).
Randomization will be performed to ensure homogeneous distribution of the study groups. For this purpose, a stratified block randomization method will be used in terms of age, gender, and the pre-test mean score of the Foot Care Behavior Scale. Participants will be stratified according to age (18-45 / 46-65+), gender (female/male), and Foot Care Behavior Scale pre-test score (≥45 / <45).
To ensure allocation concealment, the "Sequentially Numbered, Opaque, Sealed Envelopes" (SNOSE) method will be used. The randomization schedule will be created via computer software by an independent person not directly involved in the study, and the sealed envelopes prepared according to this schedule will be opened sequentially after the participant is included in the study and the pre-test assessment is completed. Thus, the researcher's prior knowledge of which group (intervention or control) the next participant will be assigned to and the creation of selection bias will be prevented.
In the study, blinding cannot be performed because the researchers will know the groups in which the individuals are included. However, blinding will be applied in data analysis to minimize measurement bias. In the dataset, the groups will be coded as "Group A" and "Group B" and analyzed by an independent biostatistics expert who does not know which group received the intervention.
The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will not receive any intervention and will receive their routine care and treatment. |
| Study | Experimental | Behavioral: "Health for My Feet" virtual reality program.This group will receive VR-based intervention and will receive their routine care and treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being over 18 years of age
- Having been diagnosed with type 2 diabetes for at least one year
- Having a risk level of 0, 1, or 2 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification
- Having completed primary education or higher
- Not having hearing, speech, or visual impairments
Key exclusion criteria (4 listed)
- Having previously had a diabetic foot ulcer or currently having a diabetic foot ulcer
- Having a severe/uncontrolled comorbid disease
- Wishing to withdraw 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 |
|---|---|---|
| "Health for My Feet" virtual reality program.In addition to their routine treatment and monitoring, individuals in this group will be included in the "Health for My Feet" virtual reality program. | Behavioural | Study |
Primary outcome
Change in Total Score of the Diabetic Foot Knowledge Scale
Time frame: Baseline, 1 month post-intervention, and 3 months follow-up
The outcome is the change in the total score of the Diabetic Foot Knowledge Scale (DFKS). The scale assesses participants' knowledge regarding diabetic foot care. Scores are calculated by summing item responses, with higher scores indicating greater knowledge. The change in total score will be calculated by comparing baseline (pre-test), 1-month post-intervention, and 3-month follow-up assessments.
1 secondary outcome
Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form
Time frame: Baseline and 3 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 16 Mar 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing "Health for My Feet" virtual reality program. in people with Diabetic Foot - Telemedical Monitoring and Diabetic, run by Ege University.
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 8 inclusion and 4 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Total Score of the Diabetic Foot Knowledge Scale (time frame: Baseline, 1 month post-intervention, and 3 months follow-up). 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 Mar 2026.