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临床试验/NCT04100551
NCT04100551已完成不适用

Relationship Between Chronic Renal Disease Gradation and Risk Stratification for Chronic Ulcer on the on the Diabetic Foot

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
relationship between renal function and podological grade

研究概览

简要总结

Context and hypothesis: The prevalence of diabetes mellitus keeps going to increase, due to the ageing of the population and the high prevalence of overweight and obesity. Thus about 5% of the French population is said to have diabetes according to the national health insurance reimbursement data estimations. 15 to 20% of diabetic patients will have a foot chronic ulcer in their lifetime. Nowadays, diabetes is still the leading cause of non-traumatic amputation in France, amputation being very often preceded by a trophic disorder. Thus, the person with diabetes has a 7-fold risk of amputation. For the year 2013, in France, incidence rates of hospitalizations for lower limb amputations and foot wounds in the diabetic population were 252/100000 and 668/100000 respectively. In an attempt to prevent the risk of foot wounds in people with diabetes, the International Working Group on the Diabetic Foot (IWGDF) has established foot grades associated with an increased risk of foot wounds. These grades are now used by health authorities to calibrate their care offer such as reimbursements for podiatry care. Chronic kidney disease is one of the major complications of diabetes. In 2013, according to data from the French registry (REIN), 4,856 diabetics started renal replacement therapy in 2016, representing 46% of the newly dialyzed population. This represents a relative risk 9.2 times higher than in the general population. The Investigators hypothesize that beyond the risk of wound, there is a link between the stage of chronic renal disease and the risk of foot ulcer grade as defined by the IWGDF. The link between chronic renal disease and this common marker of foot risk has never been studied to our knowledge. The long-term objective, beyond this study, is to improve patient pathways and thus improve the prevention of foot wounds in diabetics with renal insufficiency. This is all the more true since prevention actions in the dialysis population have already shown their effectiveness on a large scale on the risk of amputation.

Protocol : All patients with a diabetes mellitus who consult diabetology and nephrology services at the Montpellier University Hospital will be included in this study. The consultation wil be the same as usual. The Investigators will ask for the history of diabetes, the history of complications, the current treatments and the Investigators will make a standardized clinical examination of feet with a foot risk gradation according to the IWGDF.The investigators will report the standard biologicals values.

详细描述

A simple standardization of the clinical examination (Foot Risk Grading), history collection and biological data will be organized by the study sponsors.

List of collected data, origin and circuit of the data:

Entry of patient data (clinical, biological and additional examinations) on a database registered at the University Hospital of Montpellier on a secure server.

Data from :

  • Computerized medical records and consultation letters.
  • The question form completed by the physician- The results of biological examinations carried out outside or inside the university hospital vested with a standardized standard prescription form

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

relationship between renal function and podological grade

时间窗: 1 day

Gradation of the Risk stratification for chronic ulcer on the diabetic foot by the IWGDF Chronic renal disease gradation with the Enzymatic measure of creatininemia. Clearance calculation with CKD-EPI. (CKD-EPI \>90 ; 60-90 ; 45-60 ; 30-45 ; 15-30 ; \< 15 ; Dialysis)

次要结局

  • factors associated with the occurrence of complications and comorbidities(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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