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

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University Hospital, Montpellier

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT04100551

BioSeek: nct04100551

Ключови думи

Резюме

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.

Описание

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

All the data corresponds to the current annual or infra-annual follow-up of patients consulting for the pathologies studied: Diabetes and renal failure.

The data will be anonymized by a chronic search entry number and 1st letter of the surname and first name.

The statistical analysis of the data will be carried out internally at the Montpellier University Hospital, in collaboration with the Medical Information Department, in accordance with the partnerships already in place between our teams.

Data :

Simple demographic characteristics: Age, gender Clinical history: Longstanding diabetes, diabetic retinopathy, diabetic maculopathy, ischemic heart disease, history of stroke, lower limb arteriopathy, known gastroparesis, high blood pressure, hypercholesterolemia, microalbuminuria or known proteinuria.

Clinical features: BMI, lower limb neuropathy - monofilament test error, pulse abolition

. Treatments: diabetes, type of kidney substitution, other treatments Toxic: Tobacco, Alcohol Quality of patient follow-up: date of last ophthalmic consultation (For each diabetic person: one consultation per year is recommended - this criterion is monitored by health insurance as a quality criterion for follow-up)

Biological assessment: Creatinemia, Calcaemia, Phosphatemia, Magnesemia, 1.25OHVitD, 25OHVitD, 25OHVitD, Natremia, Kalemia, Albuminaemia, PTH, CRP, Uric acid, HbA1C, Hemoglobinaemia, HDL, LDL, Triglyceridaemia, Cholesterol, Albuminuria/Creatinuria ratio, Proteinuria/Creatinuria ratio

Дати

Последна проверка:	05/31/2020
Първо изпратено:	09/12/2019
Очаквано записване подадено:	09/22/2019
Първо публикувано:	09/23/2019
Изпратена последна актуализация:	06/03/2020
Последна актуализация публикувана:	06/04/2020
Действителна начална дата на проучването:	09/30/2019
Приблизителна дата на първично завършване:	04/30/2020
Очаквана дата на завършване на проучването:	05/29/2020

Състояние или заболяване

Chronic Renal Disease

Diabetic Foot

Фаза

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Метод за вземане на проби	Probability Sample
Приема здрави доброволци	Да
Критерии	Inclusion criteria: - Diabetes type 1 or 2 - Consultation in nephrology or diabetology at the Montpellier university hospital Exclusion criteria: - Solid Organ transplant - Pregnancy

Резултат

Първични изходни мерки

1. relationship between renal function and podological grade [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)

Вторични изходни мерки

1. factors associated with the occurrence of complications and comorbidities [1 day]

Cardiovascular disease

2. factors associated with the occurrence of complications and comorbidities [1 day]

current biological rates

3. factors associated with the occurrence of complications and comorbidities [1 day]

HbA1C

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

Ключови думи

никотин

uric acid

язва

гастропареза

диабетна ретинопатия

макулна дегенерация

инсулт

протеинурия

диабетно стъпало

захарен диабет

хиперхолестеролемия

затлъстяване

исхемична болест на сърцето

хемодиализа