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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

NCT ID NCT07813676

NEW Sponsor: Siirt University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
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By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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). 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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus (T2DM)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Siirt Training and Research Hospital

    Siirt, Siirt, 56100, Turkey (Türkiye)

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