Five-year Mortality Rate in People With Diabetic Foot Ulcer (DIAFOOT)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Paris, France, 75013
- AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- type 1 or 2 diabetes
- consultation for new diabetic foot ulcer during the year 2010
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Diabetic patients with DFU
Diabetic patients with DFU diagnosed in 2010
|
Blood samples drawn during hospitalisations when needed
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIC1421-18-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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