Prognostic Determinants in Patients With Diabetic Foot Ulcer.
NCT ID: NCT04533152
Last Updated: 2026-01-15
Study Results
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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RECRUITING
1000 participants
OBSERVATIONAL
2021-11-24
2029-11-30
Brief Summary
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The aim of the study is to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France, in order to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants.
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Detailed Description
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In addition, to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants, the investigators will also assess all changes in health-related quality of life (HRQoL), and the economic impact related to DFU (cost of illness study) for the French healthcare system, using SNDS claims databases. A 3-year inclusion period will start during 2020, and each participant will be followed for 5 years or until death.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Foot infection without open skin wound,
* Intercurrent disease prohibiting participation in an observational study,
* Pregnancy or breastfeeding
* Curatorship or guardianship
* Prisoners -- Patient currently participating to more than one other clinical study (interventional or observational, 2 study maximum including PDF) or currently participating to another study interfering with standard care of diabetic foot
18 Years
ALL
No
Sponsors
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Fondation Francophone pour la Recherche sur le Diabete
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU Côte de Nacre
Caen, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CHU de Bocage Sud
Dijon, , France
CHU de La Réunion - Site Sud
La Réunion, , France
Groupe Hospitalier de La Rochelle Ré Aunis
La Rochelle, , France
Hôtel Dieu
Le Creusot, , France
CHRU de Lille - Hôpital Claude Huriez
Lille, , France
AP - HM - Hôpital de la Conception
Marseille, , France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, , France
CHU de Nantes Hôpital Nord Laennec
Nantes, , France
CH Pierre Bérégovoy
Nevers, , France
CHU de Nice - Hôpital l'Archet 2
Nice, , France
CHU Nîmes - Hôpital universitaire Carémeau
Nîmes, , France
AP-HP - Hôpital Bichat
Paris, , France
AP-HP - Hôpital Lariboisière
Paris, , France
AP-HP - Hôpital Pitié-Salpétrière
Paris, , France
Hôpital Paris Saint Joseph
Paris, , France
Hopital Haut-Leveque
Pessac, , France
HCL - Hôpital Lyon sud
Pierre-Bénite, , France
CHU de la Milétrie
Poitiers, , France
CHU de Rouen
Rouen, , France
Centre Hospitalier Saint Benoit
Saint-Benoît, , France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, , France
Maison de Santé Protestante Bagatelle - Hôpital Bagatelle
Talence, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
CHU de la Martinique
Fort-de-France, , Martinique
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2019/70
Identifier Type: -
Identifier Source: org_study_id
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