Five-year Mortality Rate in People With Diabetic Foot Ulcer

Groupe Hospitalier Pitie-Salpetriere347 enrolled

Overview

As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU). This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also induces a dramatic decrease in physical, emotional, and social functioning for patients. Oftenly associated with advanced micro and macrovascular complications, high morbidity and a greater risk of premature death (mainly by Ischemic Heart Disease) occure. Only few studies explored DFU patients' long term survival: the few datas coming from cohorts in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis. But life expectancy in diabetics patients imporved during last decade. So the main objective of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was diagnosed in 2010. Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.

Study Type

OBSERVATIONAL

Enrollment

347

Conditions

Diabetes Mellitus Diabetic Foot Diabetes Complications

Interventions

blood samplesBIOLOGICAL

Blood samples drawn during hospitalisations when needed

Clinical exam and DFU medical caresOTHER

Clinical exam and DFU's medical cares at each visit (planned evry 1 to 3 months), during all the 5 years follow up, or until death.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * type 1 or 2 diabetes * consultation for new diabetic foot ulcer during the year 2010 Exclusion Criteria: None

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, France

Outcomes

Primary Outcomes

Mortality rate 5 years after DFU diagnosis

Five years after DFU diagnosis, patients are called by phone to enquire their health. If patients are dead, family tell us. If no family is available, the City Hall is called to check the death list.

Time frame: 5 years

Secondary Outcomes

Risks factors correlated to mortality rate among DFU patients diagnosed in 2010

All relevants staisticals associations between mortality rate and DFU diagnosed in 2010

Time frame: 5 years

Data from ClinicalTrials.gov

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