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Five-year Mortality Rate in People With Diabetic Foot Ulcer

NCT ID: NCT03782129

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Diabetic Foot Diabetes Complications

Keywords

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diabetes mellitus diabetic foot mortality rate diabetes complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients with DFU

Diabetic patients with DFU diagnosed in 2010

blood samples

Intervention Type BIOLOGICAL

Blood samples drawn during hospitalisations when needed

Clinical exam and DFU medical cares

Intervention Type OTHER

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.

Interventions

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blood samples

Blood samples drawn during hospitalisations when needed

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CIC1421-18-16

Identifier Type: -

Identifier Source: org_study_id