Effects of an Animated Mobile Application on Diabetic Foot Ulcer Management

NCT06977048 | Active Not Recruiting

• 1 other identifier: SBU-H-MG-06
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the effect of education delivered through an animation-based mobile application on the knowledge level, self-efficacy, wound size, and metabolic parameters of individuals with diabetic foot ulcers.

Conditions

Diabetic Foot Ulcers (DFU)

Keywords

diabetic foot; animation

Outcome Measures

Primary Outcomes (3)

• Change in Diabetic Foot Ulcer Size (cm²)

  This outcome measures the change in the surface area (cm²) of the diabetic foot ulcer from baseline (Week 0) to the end of the intervention (Week 12). The wound size is calculated using the formula length × width (cm × cm).

  aseline (Week 0) Follow-up (Week 12) (Optional intermediate check at Week 8)

• The Diabetic Foot Care Self-Efficacy Scale (DFCSES)

  The Diabetic Foot Care Self-Efficacy Scale (DFCSES), originally developed by Quarles (2005) and adapted into Turkish by Kır Biçer (2011), will be used to assess participants' self-efficacy regarding diabetic foot care. The scale consists of 9 items rated on a scale from 0 (not confident at all) to 10 (completely confident), with total scores ranging from 0 to 90. Higher scores reflect greater self-efficacy in diabetic foot care. The change in total score from baseline to 12 weeks post-intervention will be evaluated.

  Baseline (Week 0) Follow-up (Week 12)

• Change in Diabetic Foot Knowledge Score

  Knowledge of diabetic foot care will be measured using a 5-item subscale from the Diabetes Knowledge Questionnaire-24 (DKQ-24), originally developed by Garcia et al. and adapted into Turkish by Biçer. Each item is answered as "Yes," "No," or "I don't know." Total scores range from 0 to 5, with higher scores reflecting greater knowledge of diabetic foot care. The change in score from baseline to 12 weeks post-intervention will be assessed.

  Baseline (Week 0) Follow-up (Week 12)

Secondary Outcomes (7)

• Change in HbA1c (%)

  Baseline (Week 0) Follow-up (Week 12)

• Change in Fasting Blood Glucose (mg/dL)

  Baseline (Week 0) Follow-up (Week 12)

• Change in Triglycerides (mg/dL)

  Baseline (Week 0) Follow-up (Week 12)

• Change in HDL Cholesterol (mg/dL)

  Baseline (Week 0) Follow-up (Week 12)

• Change in LDL Cholesterol (mg/dL)

  Baseline (Week 0) Follow-up (Week 12)

Study Arms (2)

Experimental - Mobile Application-Based Education Group (Intervention Group)

OTHER

Participants receive an educational intervention via a mobile application with animation-based videos and modules on diabetic foot ulcer (DFU) care. The intervention spans 12 weeks and includes initial training and weekly follow-ups.

Other: Mobile Application-Based Educational Program

No Intervention - Control Group

OTHER

Participants in this group receive no educational intervention and continue their usual care.

Other: Standard care

Interventions

Mobile Application-Based Educational Program OTHER

Week 0: Participants are informed about the study and trained in the use of the mobile application. The mobile app is installed on their smartphones. Educational animation videos and modules are watched with the researcher in a predefined order. Questions about animations are answered. Videos are downloaded to the participant's phone. DFU photographs are recorded. Weeks 1-12: Participants are instructed to use the app regularly between weeks 5-12. Video watching days and durations are logged using a tracking form. Weekly push notifications remind participants to use the app. Weekly phone calls are made to assess engagement using a structured checklist. DFU photographs are taken at weeks 8 and 12. At week 12, data are collected in person, including: DFU size (length × width) with disposable paper ruler Metabolic parameters from blood tests Wagner-Meggitt classification Re-ulceration assessment

Experimental - Mobile Application-Based Education Group (Intervention Group)

Standard care OTHER

Participants provide consent and receive baseline information. DFU photographs are taken at baseline, week 8, and week 12. At week 12, the same outcome measures as the intervention group are collected. After the study ends, participants are provided with access to the mobile application.

No Intervention - Control Group

Eligibility Criteria

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

You may qualify if:

• Having a diagnosis of diabetic foot ulcer, having stage 1-2 diabetic foot ulcer according to Wagner classification system, being between the ages of 18-65, being literate, having and using a mobile phone with IOS and ANDROID operating system, volunteering to participate in the study

You may not qualify if:

• Users who want to withdraw from the research, the patient's exitus during the research process, users who do not log in to the mobile application once a week during the implementation process of the research (twelve weeks) will be excluded from the research.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Gülhane Training and Research Hospital, University of Health Sciences, Turkey

Ankara, Keçiören, 06300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ayla D Demirtaş

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

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: PHD student

Model Details: Patients will be divided into intervention and control groups by simple randomisation.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 16, 2025
• Study Start: April 30, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 25, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)