Five-year Mortality Rate in People With Diabetic Foot Ulcer

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2018

Detailed Description

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.

Interventions

  • Biological: blood samples
    • Blood samples drawn during hospitalisations when needed
  • Other: Clinical exam and DFU medical cares
    • 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.

Arms, Groups and Cohorts

  • Diabetic patients with DFU
    • Diabetic patients with DFU diagnosed in 2010

Clinical Trial Outcome Measures

Primary Measures

  • Mortality rate 5 years after DFU diagnosis
    • Time Frame: 5 years
    • 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.

Secondary Measures

  • Risks factors correlated to mortality rate among DFU patients diagnosed in 2010
    • Time Frame: 5 years
    • All relevants staisticals associations between mortality rate and DFU diagnosed in 2010

Participating in This Clinical Trial

Inclusion Criteria

  • type 1 or 2 diabetes
  • consultation for new diabetic foot ulcer during the year 2010

Exclusion Criteria

None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Groupe Hospitalier Pitie-Salpetriere
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joe Elie Salem, Assistant director, clinical investigation center Paris Est – Groupe Hospitalier Pitie-Salpetriere

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