Diabetes Mellitus, Diabetic Foot Ulcer (DFU)
Conditions
Keywords
Diabetic Foot Ulcer, iabetic Foot Self-Care Mobile Health, mHealth, Digital Health, Artificial Intelligence, Medication Adherence
Brief summary
This study aims to evaluate DiaFootCare, a mobile health application designed to support self-care and monitoring among adults with diabetic foot ulcers. The application provides educational and self-care support, medication and care reminders, wound monitoring using standardized foot photographs, and communication of relevant information to support pharmacist-led monitoring. The study will evaluate the usability and effectiveness of DiaFootCare among patients with diabetic foot ulcers receiving care at the National Diabetes and Endocrine Centre in Oman. Participants using DiaFootCare will be compared with participants receiving usual care. The study will assess outcomes related to diabetic foot self-care, medication adherence, glycemic control, wound healing, and participants' use of and engagement with the application.
Interventions
BEHAVIORALDiaFootCare Mobile Application
Participants will use the DiaFootCare mobile application for three months in addition to usual diabetic foot care. The application provides diabetic foot self-care education, medication and self-care reminders, guided wound-image capture, wound monitoring and progress visualization, and pharmacist-led monitoring and support.
OTHERUsual Diabetic Foot Care
Participants will receive routine diabetic foot ulcer care provided by the National Diabetes and Endocrine Centre according to usual clinical practice. They will not receive access to the DiaFootCare mobile application during the three-month study period.
Sponsors
Oman Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* \- Adults aged 40 to 60 years. * Diagnosed with type 1 or type 2 diabetes mellitus. * Have an active diabetic foot ulcer. * Receiving diabetic foot care at the National Diabetes and Endocrine Centre in Oman. * Have access to a compatible smartphone and internet connection. * Able to understand Arabic and use the DiaFootCare application after receiving instructions. * Willing and able to provide written informed consent and complete the three-month follow-up.
Exclusion criteria
* Severe cognitive, visual, physical, or communication impairment that prevents use of the application or completion of study assessments. * A diabetic foot condition requiring immediate hospitalization or urgent major surgical intervention. * Unable or unwilling to complete the three-month follow-up. * Concurrent participation in another intervention study that could affect the study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Closure (100% Epithelialization): | Baseline and 3 months | he primary effectiveness outcome is complete wound closure-defined as 100% epithelialization of the wound surface with no measurable length, width, or depth-assessed by a podiatrist masked to group allocation at Week 12 (12 weeks from baseline). |
| Wound dimensions (length, width, area) | Baseline, Week 4, Week 8, Week 12 | Wound dimensions-comprising length, width, and area-constitute the Primary Effectiveness Outcome in the DiaFootCare RCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control Measures | 3 MONTHS | HbA1c levels, extracted from existing medical records, where routinely available to avoid an additional dedicated blood draw. The laboratory method and/or assay used for measuring HbA1c will be recorded to assure consistency. Where possible, measurements taken by the same lab are used |
| Self-Efficacy | 3 months | Foot Care Confidence Scale Diabetes Management Self-Efficacy Scale Forward-backward translation and cognitive debriefing have been used to translate and adapt for the Omani population |
Countries
Oman
Contacts
CONTACTRaqiya AL Mamari
Outcome results
None listed