Diabetes Mellitus Clinical Trial
— DIAFOOTOfficial title:
Five-year Mortality Rate in People With Diabetic Foot Ulcer
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 |
Verified date | December 2018 |
Source | Groupe Hospitalier Pitie-Salpetriere |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM | Paris |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Pitie-Salpetriere |
France,
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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