Five-year Mortality Rate in People With Diabetic Foot Ulcer

Diabetes Mellitus Clinical Trial

— DIAFOOT  

Official title:

Five-year Mortality Rate in People With Diabetic Foot Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782129
• Other study ID #: CIC1421-18-16
• Status: Completed
• 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
• 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:

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetic Foot
• Foot Ulcer

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