DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman

N/ANot Yet RecruitingNCT07815275

Oman Ministry of Health139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Diabetic Foot Ulcer (DFU)Diabetes Mellitus

Interventions

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Complete Wound Closure (100% Epithelialization):

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).

Time frame: Baseline and 3 months

Wound dimensions (length, width, area)

Wound dimensions-comprising length, width, and area-constitute the Primary Effectiveness Outcome in the DiaFootCare RCT

Time frame: Baseline, Week 4, Week 8, Week 12

Secondary Outcomes

Glycemic Control Measures

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

Time frame: 3 MONTHS

Self-Efficacy

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

Time frame: 3 months