Diabetic Foot Ulcer (DFU)DiaFootCareNCT07815275
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
A study testing DiaFootCare Mobile Application and Usual Diabetic Foot Care in people with Diabetic Foot Ulcer (DFU) and Diabetes Mellitus, run by Oman Ministry of Health at 1 site in Oman.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Diabetes Mellitus
- What is being tested?
- DiaFootCare Mobile Application and Usual Diabetic Foot Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteOman
- Study dates
- 13 Sep 2026to 13 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site
National Diabetes and Endocrine Centre
Muscat, 119
Issa Al Salmi, 0096822357280, nhrc-dgp@moh.gov.om
About this study
Official title: DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in the National Diabetes and Endocrine Centre in Oman
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.
- Conditions
- Diabetic Foot Ulcer (DFU), Diabetes Mellitus
- Being tested
- DiaFootCare Mobile Application, Usual Diabetic Foot Care
- Keywords
- Diabetic Foot Ulcer, iabetic Foot Self-Care Mobile Health, mHealth, Digital Health, Artificial Intelligence, Medication Adherence
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaFootCare Mobile ApplicationBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DiaFootCare Intervention | Experimental | 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. Receives: Behavioral: DiaFootCare Mobile Application; Other: Usual Diabetic Foot Care |
| Usual Care Control | Active comparator | Participants assigned to this arm will receive the usual diabetic foot care provided by the National Diabetes and Endocrine Centre without access to the DiaFootCare mobile application during the three-month study period. Receives: Other: Usual Diabetic Foot Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start13 Sep 2026 (estimated)
- Primary completion13 Jun 2027 (estimated)
- Study completion13 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Raqiya Mohammed Al-Mamari, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815275
- Sponsor's protocol ID
- MoH/CSR/24/29355
- Acronym
- DiaFootCare
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.