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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03782129
Other study ID # CIC1421-18-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2009
Est. completion date December 2018

Study information

Verified date December 2018
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- type 1 or 2 diabetes

- consultation for new diabetic foot ulcer during the year 2010

Exclusion Criteria:

Study Design


Intervention

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.

Locations

Country Name City State
France AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 years
Secondary Risks factors correlated to mortality rate among DFU patients diagnosed in 2010 All relevants staisticals associations between mortality rate and DFU diagnosed in 2010 5 years
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