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CompletedNCT04100551NEPHROPODUpdated Jun 5, 2020

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

An observational study in Chronic Renal Disease and Diabetic Foot, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 500 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Solid Organ transplant
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. relationship between renal function and podological grade

    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)

    Time frame: 1 day

Secondary outcomes

  1. factors associated with the occurrence of complications and comorbidities

    Cardiovascular disease

    Time frame: 1 day

  2. factors associated with the occurrence of complications and comorbidities

    current biological rates

    Time frame: 1 day

  3. factors associated with the occurrence of complications and comorbidities

    HbA1C

    Time frame: 1 day

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04100551
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Sep 24, 2019
Start date
Oct 1, 2019
Primary completion
May 1, 2020
Completion
May 30, 2020
Last update
Jun 5, 2020

Study contacts

Ariane SULTAN, PR
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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