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Five-year Mortality Rate in People With Diabetic Foot Ulcer (DIAFOOT)

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ClinicalTrials.gov Identifier: NCT03782129
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, 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.


Condition or disease Intervention/treatment
Diabetes Mellitus Diabetic Foot Diabetes Complications Biological: blood samples Other: Clinical exam and DFU medical cares

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.


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Study Type : Observational
Actual Enrollment : 347 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Five-year Mortality Rate in People With Diabetic Foot Ulcer
Actual Study Start Date : March 2009
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diabetic patients with DFU
Diabetic patients with DFU diagnosed in 2010
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.




Primary Outcome Measures :
  1. Mortality rate 5 years after DFU diagnosis [ Time Frame: 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 :
  1. Risks factors correlated to mortality rate among DFU patients diagnosed in 2010 [ Time Frame: 5 years ]
    All relevants staisticals associations between mortality rate and DFU diagnosed in 2010



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patients with a DFU diagnosed in 2010
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782129


Locations
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France
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere

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Responsible Party: Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03782129     History of Changes
Other Study ID Numbers: CIC1421-18-16
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
diabetes mellitus
diabetic foot
mortality rate
diabetes complications

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetic Foot
Foot Ulcer
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetic Neuropathies
Foot Diseases