DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman (DiaFootCare)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raqiya AL Mamari
- Phone Number: 0096896794009
- Email: raqiyaalmamari@gmail.com
Study Locations
-
-
-
Muscat, Oman, 119
- Recruiting
- National Diabetes and Endocrine Centre
-
Contact:
- Issa Al Salmi
- Phone Number: 0096822357280
- Email: nhrc-dgp@moh.gov.om
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - Adults aged 30 to 80 years.
- Diagnosed with type 1 or type 2 diabetes mellitus.
- Have an active diabetic foot ulcer.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DiaFootCare Intervention
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. |
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. |
|
Active Comparator: Usual Care Control
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete Wound Closure (100% Epithelialization):
Time Frame: Baseline and 3 months
|
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). |
Baseline and 3 months
|
|
Wound dimensions (length, width, area)
Time Frame: Baseline, Week 4, Week 8, Week 12
|
Wound dimensions-comprising length, width, and area-constitute the Primary Effectiveness Outcome in the DiaFootCare RCT |
Baseline, Week 4, Week 8, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic Control Measures
Time Frame: 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 |
3 MONTHS
|
|
Change in Foot Care Confidence (Foot Care Confidence Scale)
Time Frame: 3 months
|
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. |
3 months
|
|
Change in Diabetes Management Self-Efficacy (Diabetes Management Self-Efficacy Scale)
Time Frame: 3 months
|
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. |
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetic Angiopathies
- Diabetes Complications
- Skin Diseases
- Skin Ulcer
- Leg Ulcer
- Diabetic Neuropathies
- Foot Ulcer
- Behavior
- Nutritional and Metabolic Diseases
- Skin and Connective Tissue Diseases
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Diabetes Mellitus
- Diabetic Foot
- Medication Adherence
Other Study ID Numbers
- MoH/CSR/24/29355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.