The Pathological Relationships Between Chronic Kidney Disease (CKD)and the Development of Lower Limb Threatening Complications
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is to identify the neurovascular risk factors for foot ulceration as renal function declines, and to develop a suitable foot protection programme for CKD patients.
研究概览
简要总结
Foot ulceration is a risk factor that has been associated with early death in patients with chronic kidney disease. Little is known about the relationship between these risk factors that develop in patients with kidney failure and the onset of lower limb threatening foot ulcers.
Diabetes is a major cause of both kidney disease and foot ulceration; however a previous study reported that a significant proportion of kidney failure patients on haemodialysis treatment without a diagnosis of diabetes also had these risk factors that could lead to foot ulceration.
The aim of this study will be to identify these risk factors associated with lower limb threatening disease in patients with advanced kidney failure. In addition a robust screening tool will be developed to address the reliability and validity of current screening methods deemed to be gold standard in the assessment of diabetic foot disease in this Chronic Kidney Disease population.
It is important to follow the progression of these risk factors as the kidney failure worsens. The study also intends to screen patients as they start dialysis treatment and follow their progress with respect to risk factors known to predispose to foot ulceration over their first year of treatment. The proposed outcome from this study is to develop a strategy to identify patients with kidney failure that are at risk of foot ulceration and intervene at an early point to prevent the life threatening complications associated foot disease.
详细描述
The risk factors contributing to foot ulceration in the diabetic population are well published, and an abundance of these publications demonstrate the acceleration of risk factors in association with diabetic nephropathy.
It is also apparent that there are risk factors present in the non-diabetic Chronic Kidney Disease population but much less information about there prevalence and progression is published. A recent pilot study reported significant risk factors for foot ulceration in a population of subjects receiving haemodialysis therapy in the absence of diabetes mellitus.
The study will aim to increase the understanding of Chronic Kidney Disease (CKD) and the development of foot ulceration in the diabetic and non-diabetic Chronic Kidney Disease population as renal failure progresses and dialysis is initiated.
Design and methodology:
Patient Identification:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 4/5 Chronic Kidney Disease (EGFR <30ml/min) Over 18 years of age
排除标准
- •CKD stage 1-3 (eGFR >31)
- •Inability or refusal to give informed consent
- •Life expectancy < 6 months
结局指标
主要结局
The primary outcome of the study is to identify the neurovascular risk factors for foot ulceration as renal function declines, and to develop a suitable foot protection programme for CKD patients.
时间窗: 4 years
次要结局
- The secondary outcome measure is to identify whether dialysis modality choice influence foot ulcer development and should this be used to inform patient choice of dialysis.(4 years)