Not Yet RecruitingNot Applicable

Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes

70 participantsStarted 2026-04-16

Plain-language 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. 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Total Score of the Diabetic Foot Knowledge Scale

Timeframe: Baseline, 1 month post-intervention, and 3 months follow-up

Trial details

NCT IDNCT07473050

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Diabetic Foot - Telemedical Monitoring trials