An interventional study of DiaFootCare Mobile Application and Usual Diabetic Foot Care in Diabetic Foot Ulcer (DFU) and Diabetes Mellitus, sponsored by Oman Ministry of Health. Recruiting at 1 site in Oman. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Oman Ministry of Health · Not applicable, Interventional, and Treatment
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 108 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.
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The criteria were revised on the registry on Nov 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive usual diabetic foot care plus access to the DiaFootCare mobile application for three months. 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.
Behavioral: DiaFootCare Mobile Application · Other: Usual Diabetic Foot Care
Participants assigned to this arm will receive the usual diabetic foot care provided without access to the DiaFootCare mobile application during the three-month study period.
Other: Usual Diabetic Foot Care
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.
Participants will receive routine diabetic foot ulcer care according to usual clinical practice. They will not receive access to the DiaFootCare mobile application during the three-month study period.
Complete Wound Closure (100% Epithelialization):
The 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
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
Change in Foot Care Confidence (Foot Care Confidence Scale)
Foot care self-efficacy was assessed using the Foot Care Confidence Scale (FCCS), a 12-item instrument translated via forward-backward translation and cognitive debriefing for the Omani population. Each item is rated on a 5-point Likert-type scale. Total scores range from a minimum of 12 to a maximum of 60, with higher scores indicating greater confidence in performing foot self-care.
Time frame: 3 months
Change in Diabetes Management Self-Efficacy (Diabetes Management Self-Efficacy Scale)
Self-efficacy in diabetes management was assessed using the Diabetes Management Self-Efficacy Scale (DMSES), a 20-item instrument translated via forward-backward translation and cognitive debriefing for the Omani population. Each item is rated on a 1-5 numerical scale reflecting the respondent's level of efficacy expectation. Total scores range from a minimum of 20 to a maximum of 100, with higher scores indicating greater self-efficacy in diabetes management.
Time frame: 3 months
Plan to share: No — Individual participant data will not be shared because the study includes sensitive clinical information and wound images, and external data sharing is not included in the current ethics approval and participant consent.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Oman Ministry of Health