Five-year Mortality Rate in People With Diabetic Foot Ulcer

Completed

• Conditions: Diabetes Complications; Diabetes Mellitus; Diabetic Foot
• Interventions: Biological: blood samples; Other: Clinical exam and DFU medical cares

• Registration Number: NCT03782129
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Study First Posted: 2018-12-20
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients with DFU	blood samples	Diabetic patients with DFU diagnosed in 2010
Diabetic patients with DFU	Clinical exam and DFU medical cares	Diabetic patients with DFU diagnosed in 2010

Primary Outcome Measures

Name	Time	Method
Mortality rate 5 years after DFU diagnosis	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.

Secondary Outcome Measures

Name	Time	Method
Risks factors correlated to mortality rate among DFU patients diagnosed in 2010	5 years	All relevants staisticals associations between mortality rate and DFU diagnosed in 2010

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France