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临床试验/NCT05040009
NCT05040009Unknown不适用

Foot Care and Footwear Assessment in Diabetic Patients and Its Relation to Diabetic Complications.

Assiut University2 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
259
试验地点
2
主要终点
Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment

研究概览

简要总结

Screening for diabetic foot in patients attending at Diabetic center at Assiut university and its relations to diabetic microvascular complications (nephropathy, neuropathy and retinopathy) and macrovascular complications (stroke , myocardial infarction and peripheral arterial diseases).

Footwear assessment in diabetic patient. Evaluation of integrated foot care program in moderate and high-risk patients for diabetic foot.

Evaluation of knowledge and practice of diabetic foot

详细描述

The International Diabetes Federation (IDF) has identified Egypt as the ninth leading country in the world for the number of patients with T2D. The prevalence of T2D in Egypt was almost tripled over the last 2 decades. This sharp rise could be attributed to either an increased pattern of the traditional risk factors for T2D such as obesity and physical inactivity and change in eating pattern or other risk factors unique to Egypt .

Diabetic foot complications are the most common cause of non-traumatic lower extremity amputations in the industrialized world, may cause death or physical and psychical disability, has a great impact on quality of life, and represents a high cost for society ( .

The term diabetic foot encompasses any lesion in the feet: infection, ulcer, and destruction of deep tissues occurring as the result of diabetes and its complications .

The absence of symptoms in a person with diabetes does not exclude foot disease; they may have asymptomatic neuropathy, peripheral artery disease, pre-ulcerative signs, or even an ulcer.

Every diabetic patient will be subjected to

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient with diabetic mellitus

排除标准

  • Major amputation of lower limbs. End stage organ failure. Diabetic patient less than 18 years or more than
  • Pregnant diabetic women. Connective tissue disease

结局指标

主要结局

Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment

时间窗: 6 to 12 month

moderate and high risk patients for diabetic foot will undergo integrated program vs conventional treatment as regard ulcer healing and recurrence

Evaluation of knowledge and practice of diabetic foot using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)

时间窗: baseline

knowledge and practice are assessed using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)

Screening for diabetic foot and diabetic complication in patients attending at Diabetic center

时间窗: baseline

Screening for diabetic foot in patients attending at Diabetic centre at Assiut university according to IWGDF guidelines Every diabetic patient will be subjected to Fundus examination ECG The following investigations: Alb/creatinine ratio, HBA1c, lipid profile, blood urea, serum creatinine Abdominal ultrasound Ankle brachial index (ABI)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paula Rofaeel Sedky

Assistant lecturer Faculty of Medicine, ِِAssiut University

Assiut University

研究点 (2)

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