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

NCT07813676 | Not Yet Recruiting

• 1 other identifier: 2026-SİÜSBF-016
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes; Diabetic Foot; Digital Education; Foot Care Education; Self-Care Behavior; Self-Efficacy

Outcome Measures

Primary Outcomes (3)

• Change in Diabetic Foot Care Knowledge

  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

  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

  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

Study Arms (2)

Digital-Supported Foot Care Education Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Digital-Supported Foot Care Education BEHAVIORAL

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.

Digital-Supported Foot Care Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siirt University: lead

Study Sites (1)

Siirt Training and Research Hospital

Siirt, Siirt, 56100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Officials

• Zeliha Büyükbayram Genç, PhD

  Siirt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeliha Büyükbayram Genç, PhD

CONTACT

+905533931157; zeliha_bbayram@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)