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

NCT07815275 | Not Yet Recruiting

• 1 other identifier: MoH/CSR/24/29355
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Diabetic Foot Ulcer; iabetic Foot Self-Care Mobile Health; mHealth; Digital Health; Artificial Intelligence; Medication Adherence

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (3)

• Glycemic Control Measures

  3 MONTHS

• Change in Foot Care Confidence (Foot Care Confidence Scale)

  3 months

• Change in Diabetes Management Self-Efficacy (Diabetes Management Self-Efficacy Scale)

  3 months

Study Arms (2)

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.

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.

Other: Usual Diabetic Foot Care

Interventions

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.

DiaFootCare Intervention

Usual Diabetic Foot Care OTHER

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.

DiaFootCare Intervention; Usual Care Control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

National Diabetes and Endocrine Centre

Muscat, 119, Oman

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Raqiya AL Mamari

CONTACT

0096896794009; raqiyaalmamari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 13, 2026
• Primary Completion (Estimated): June 13, 2027
• Study Completion (Estimated): June 13, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)