Clinical trial NCT06977048: Effects of an Animated Mobile Application on Diabetic Foot Ulcer Management
Official title: The Effect of Education Provided Through an Animation-based Mobile Application on Disease Knowledge, Self-efficacy, Wound Size, and Metabolic Parameters in Patients With Diabetic Foot Ulcers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcers (DFU)
Keywords: diabetic foot
animation
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into intervention and control groups by simple randomisation.
Primary purpose: PREVENTION

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.

Detailed description: Diabetic foot is one of the most serious complications of diabetes, negatively affecting not only patients but also caregivers, healthcare professionals, and the broader society, both medically and economically. Peripheral neuropathy, peripheral arterial disease, microvascular and macrovascular alterations, impaired glycemic regulation, recurrent trauma, and inadequate foot care can lead to the development of diabetic foot ulcers (DFUs), which may progress to osteomyelitis. Each year, approximately 18.6 million people worldwide are affected by diabetic foot ulcers. The five-year mortality rate among these individuals is around 30%, and it exceeds 70% in those with a history of major amputation. Primary treatment approaches for DFUs include surgical debridement, offloading, treatment of peripheral arterial disease, and infection management. Additionally, therapies such as hyperbaric oxygen, wound dressings, negative pressure wound therapy, and topical oxygen are also employed in the management of diabetic foot ulcers. Compared to amputations due to other causes, a significant proportion of amputations resulting from DFUs are preventable. For this reason, education on diabetes and foot care has been shown to prevent ulcer formation and subsequently reduce amputation rates and associated morbidity.

Individuals with diabetes need to possess an adequate level of self-efficacy in order to effectively manage lifelong treatment, care, and lifestyle changes. Self-efficacy is defined as a cognitive process through which individuals believe they can influence future outcomes via environmental and social factors and thereby learn new behaviors. It is known that individuals with high self-efficacy are more actively involved in their own care and experience the chronic disease process more successfully. In diabetes management, perceived self-efficacy is considered crucial by researchers and clinicians, as it is associated with adopting a healthy lifestyle, adhering to medication and treatment regimens, and managing stress. Assessing and promoting patients' self-efficacy is a valuable tool in healthcare settings as it enhances motivation for self-care. Supporting patients in this regard may increase life expectancy and help regulate health behaviors. In a study by Bahador et al., a three-month education program for patients with diabetic foot ulcers significantly improved self-efficacy, foot ulcer care rates, and reduced re-ulceration and complication rates. Similarly, Ayaz, Dinçer, and Oğuz (2020) reviewed 26 systematic studies and 8 meta-analyses on the effects of foot care education in diabetic patients and found that such education improved patients' knowledge and behaviors. The authors emphasized the need for long-term educational interventions.

Recent advances in technology and healthcare worldwide have fostered the integration of these two fields and brought mobile health applications to the forefront. Mobile health applications are software tools used via mobile devices such as smartphones or tablets, and they offer advantages over traditional methods. These applications are employed in the management of various chronic diseases including chronic obstructive pulmonary disease (COPD), depression, dementia, and diabetes, particularly for medication adherence, rehabilitation, symptom control, and tracking medical records. In a study by Marquen et al., a mobile application combined with nursing consultation improved foot self-care among individuals with type 2 diabetes. Similarly, Kilic and Karadag developed a Mobile Diabetic Foot Self-Care System for patients with diabetes mellitus, which enhanced patients' knowledge, behaviors, and self-efficacy scores. The use of mobile applications plays a significant role in advancing mobile health technologies, and it is important that such applications are supported by daily messages, videos, and animations.

Animation is a form of educational material that uses visual simulations to present theoretical knowledge in a more accessible format. Through animation videos, key points of a topic can be highlighted to improve patient understanding, allow repeated viewing of the material, and enhance knowledge levels. In a study by Alyami et al., visual animations shown to patients with type 2 diabetes, their caregivers, and healthcare professionals were found to improve patients' perceptions and enhance the effectiveness of diabetes education. Likewise, Maisrikrod et al. developed an animated educational tool aimed at increasing community awareness in tropical regions where melioidosis and diabetes are prevalent. They concluded that such tools can serve as low-cost, adaptable health education materials.

Eligibility criteria: 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 outcomes:
measure: Change in Diabetic Foot Ulcer Size (cm²)
timeFrame: aseline (Week 0) Follow-up (Week 12) (Optional intermediate check at Week 8)
measure: The Diabetic Foot Care Self-Efficacy Scale (DFCSES)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in Diabetic Foot Knowledge Score
timeFrame: Baseline (Week 0) Follow-up (Week 12)
Secondary outcomes:
measure: Change in HbA1c (%)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in Fasting Blood Glucose (mg/dL)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in Triglycerides (mg/dL)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in HDL Cholesterol (mg/dL)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in LDL Cholesterol (mg/dL)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in Total Cholesterol (mg/dL)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
measure: Change in Body Mass Index (BMI, kg/m²)
timeFrame: Baseline (Week 0) Follow-up (Week 12)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gülhane Training and Research Hospital, University of Health Sciences, Turkey
state: Keçiören
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Ayla D Demirtaş
role: PRINCIPAL_INVESTIGATOR
References: