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OpenTrials
Completed

NCT Number: NCT03782129

Five-year Mortality Rate in People With Diabetic Foot Ulcer

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

blood samples

Biological

Blood samples drawn during hospitalisations when needed

Clinical exam and DFU medical cares

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: DIAFOOT

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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