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Five-year Mortality Rate in People With Diabetic Foot Ulcer

Five-year Mortality Rate in People With Diabetic Foot Ulcer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03782129
Acronym
DIAFOOT
Enrollment
347
Registered
2018-12-20
Start date
2009-03-31
Completion date
2018-12-31
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Complications, Diabetes Mellitus, Diabetic Foot

Keywords

diabetes mellitus, diabetic foot, mortality rate, diabetes complications

Brief 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.

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

BIOLOGICALblood samples

Blood samples drawn during hospitalisations when needed

OTHERClinical 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.

Sponsors

Groupe Hospitalier Pitie-Salpetriere
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Mortality rate 5 years after DFU diagnosis5 yearsFive 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

MeasureTime frameDescription
Risks factors correlated to mortality rate among DFU patients diagnosed in 20105 yearsAll relevants staisticals associations between mortality rate and DFU diagnosed in 2010

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026