Prognostic Determinants in Patients With Diabetic Foot Ulcer.

Study Overview
=================
Brief Summary
-----------------
The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease. The aim of the study is to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France, in order to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants.

Detailed Description
-----------------
Diabetic foot ulcer (DFU) is one of the major complications frequently observed in patients with diabetes. DFU is the leading cause of non-traumatic lower-limb amputation (LLA), and it is associated with cognitive decline, worsening quality of life and substantial economic impact on French healthcare system. DFU is also associated with excess risk of premature death with significant decrease in life expectancy despite major improvement in medical care during last decades. The hypothesis of the study is that this worse prognosis seen in DFU patients may not be fully explained by a high cardiovascular risk, but mainly linked to different causes, including inflammatory, infectious and malignant conditions. In addition, to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants, the investigators will also assess all changes in health-related quality of life (HRQoL), and the economic impact related to DFU (cost of illness study) for the French healthcare system, using SNDS claims databases. A 3-year inclusion period will start during 2020, and each participant will be followed for 5 years or until death.

Official Title
-----------------
Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.

Conditions
-----------------
Diabetic Foot Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with diabetes and DFU, defined as a foot skin ulceration or open LLA wound, measuring at least 5 mm of diameter, located below the malleolus, and induced by diabetic complications. In the case of an amputation before inclusion, the amputation stump will be considered as the main wound and not the wound that led to the amputation. Exclusion Criteria: Acute or chronic lower-limb ischemia without open skin wound, Foot infection without open skin wound, Intercurrent disease prohibiting participation in an observational study, Pregnancy or breastfeeding Curatorship or guardianship Prisoners -- Patient currently participating to more than one other clinical study (interventional or observational, 2 study maximum including PDF) or currently participating to another study interfering with standard care of diabetic foot

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFU risk score | Construct a DFU risk score equation of all-death will be computed to determine individuals with the higher risk of worse outcomes. | 5 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without active index DFU |  | At 3 and 12 months after inclusion day | 
| Survival without recurrent index DFU |  | At 12, 24, 36, 48, 60 months after inclusion day | 
| Survival without major adverse limb events (MALE) | MALE is a composite of foot infection, non-traumatic lower-limb amputation (LLA), requirement of revascularization, whichever comes first. These components will be also considered individually. | 5 years after inclusion | 
| Survival without major macrovascular events (MACE) | MACE is a composite of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death, whichever comes first. | 5 years after inclusion | 
| Survival without major microvascular events (MICE) | MICE is a composite of new-onset persistent macroalbuminuria, sustained 40% declined eGFR from baseline, ESRD, severe diabetic retinopathy or macular oedema requiring laser photocoagulation or intravitreal therapies, or diabetes-related blindness in either eye, whichever comes first. | 5 years after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Lower-limb amputation, Wound, Health-related quality of life, Cost-of-illness