Health TrialsbyHealthPanel

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

ConditionsDiabetic Foot Ulcer (DFU)Diabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorOman Ministry of Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DiaFootCare Mobile Application

    Behavioral

    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.

  • Usual Diabetic Foot Care

    Other intervention

    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.

Treatment groups

139 Participants
are divided into 2 treatment groups
Group A: DiaFootCare InterventionExperimental treatment 2 interventions
Group B: Usual Care ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oman Ministry of Health

Lead sponsor

University of Malaya

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: