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

• ClinicalTrials.gov Identifier: NCT04100551
• Recruitment Status: Completed
• First Posted: September 24, 2019
• Last Update Posted: June 5, 2020
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

Brief Summary:

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.

Condition or disease
Chronic Renal Disease; Diabetic Foot

Detailed Description:

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

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Relationship Between Chronic Renal Disease Gradation and Risk Stratification for Chronic Ulcer on the on the Diabetic Foot
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 30, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. relationship between renal function and podological grade [ Time Frame: 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)

Secondary Outcome Measures :

1. factors associated with the occurrence of complications and comorbidities [ Time Frame: 1 day ]
   Cardiovascular disease
2. factors associated with the occurrence of complications and comorbidities [ Time Frame: 1 day ]
   current biological rates
3. factors associated with the occurrence of complications and comorbidities [ Time Frame: 1 day ]
   HbA1C

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

All patients with Diabetes type 1 or type 2 over 18 years old from the consultation of Diabetology or nephrology at the Montpellier university hospital

Criteria

Inclusion criteria:

• Diabetes type 1 or 2
• Consultation in nephrology or diabetology at the Montpellier university hospital

Exclusion criteria:

• Solid Organ transplant
• Pregnancy

Contacts and Locations

Locations

France

Uhmontpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

• Study Director: Ariane SULTAN, PR; University Hospital, Montpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04100551
• Other Study ID Numbers: RECHMPL19_0431
• First Posted: September 24, 2019
• Last Update Posted: June 5, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: NC

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Diabetic Foot; Urologic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Renal Insufficiency