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NCT Number: NCT07815275

DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers 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.

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Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Complete Wound Closure (100% Epithelialization):

    Time frame: Baseline and 3 months

    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).

  2. 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

Secondary outcomes

  1. 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

  2. Self-Efficacy

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Raqiya AL Mamari

CONTACT

[email protected]

0096896794009

Sponsors and collaborators

Lead sponsor

Oman Ministry of Health

Other Gov

Registry information

Official study title

DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in the National Diabetes and Endocrine Centre in Oman

Acronym: DiaFootCare

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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