DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in the National Diabetes and Endocrine Centre in Oman
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Complete Wound Closure (100% Epithelialization):
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: DiaFootCare Mobile Application (Behavioral)
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.
干预措施: Usual Diabetic Foot Care (Other)
Usual Care Control
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.
干预措施: Usual Diabetic Foot Care (Other)
结局指标
主要结局
Complete Wound Closure (100% Epithelialization):
时间窗: 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).
Wound dimensions (length, width, area)
时间窗: Baseline, Week 4, Week 8, Week 12
Wound dimensions-comprising length, width, and area-constitute the Primary Effectiveness Outcome in the DiaFootCare RCT
次要结局
- Glycemic Control Measures(3 MONTHS)
- Self-Efficacy(3 months)
研究者
Raqiya Mohammed Al-Mamari
Mrs Raqiya
University of Malaya