Five-year Mortality Rate in People With Diabetic Foot Ulcer (DIAFOOT)
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|ClinicalTrials.gov Identifier: NCT03782129|
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
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.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Diabetic Foot Diabetes Complications||Biological: blood samples Other: Clinical exam and DFU medical cares|
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|
|Actual Enrollment :||347 participants|
|Official Title:||Five-year Mortality Rate in People With Diabetic Foot Ulcer|
|Actual Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Diabetic patients with DFU
Diabetic patients with DFU diagnosed in 2010
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782129
|AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM|
|Paris, France, 75013|