Effect of Digital-Supported Foot Care Education in Individuals With Type 2 Diabetes

September 4, 2026 updated by: Zeliha Buyukbayram Genç, Siirt University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital-Supported Foot Care Education Group
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.
Behavioral: Digital-Supported Foot Care Education
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.
No Intervention: Control Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at the end of Week 4
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.
Baseline and at the end of Week 4
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.
Baseline and at the end of Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siirt University

Investigators

  • Principal Investigator: Zeliha Büyükbayram Genç, PhD, Siirt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-SİÜSBF-016 (Other Grant/Funding Number: Siirt University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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