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Active, not recruiting Not applicable

Effects of an Animated Mobile Application on Diabetic Foot Ulcer Management

NCT06977048 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-04-30
Last updated
2025-05-16

Condition(s) studied

Diabetic Foot Ulcers (DFU)

Investigational drug(s) / intervention(s)

Mobile Application-Based Educational ProgramStandard care

Mobile Application-Based Educational Program: 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

Standard care: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change in Diabetic Foot Ulcer Size (cm²) — aseline (Week 0) Follow-up (Week 12) (Optional intermediate check at Week 8)
    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).
  • The Diabetic Foot Care Self-Efficacy Scale (DFCSES) — Baseline (Week 0) Follow-up (Week 12)
    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.
  • Change in Diabetic Foot Knowledge Score — Baseline (Week 0) Follow-up (Week 12)
    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.

Trial sites (1)

FacilityCityRegionStatus
Gülhane Training and Research Hospital, University of Health Sciences, Turkey Ankara Keçiören
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06977048 on ClinicalTrials.gov ↗ ← All trials in Turkey