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Prognostic Determinants in Patients With Diabetic Foot Ulcer.

NCT ID: NCT04533152

Last Updated: 2024-12-24

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2029-11-30

Brief Summary

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The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease.

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.

Detailed Description

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Diabetic foot ulcer (DFU) is one of the major complications frequently observed in patients with diabetes. DFU is the leading cause of non-traumatic lower-limb amputation (LLA), and it is associated with cognitive decline, worsening quality of life and substantial economic impact on French healthcare system. DFU is also associated with excess risk of premature death with significant decrease in life expectancy despite major improvement in medical care during last decades. The hypothesis of the study is that this worse prognosis seen in DFU patients may not be fully explained by a high cardiovascular risk, but mainly linked to different causes, including inflammatory, infectious and malignant conditions.

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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Diabetic Foot Ulcer

Keywords

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Diabetes mellitus Lower-limb amputation Wound Health-related quality of life Cost-of-illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Adults with diabetes and DFU, defined as a foot skin ulceration or open LLA wound, measuring at least 5 mm of diameter, located below the malleolus, and induced by diabetic complications. In the case of an amputation before inclusion, the amputation stump will be considered as the main wound and not the wound that led to the amputation.

Exclusion Criteria

* Acute or chronic lower-limb ischemia without open skin wound,
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Francophone pour la Recherche sur le Diabete

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie PREAUBERT-HAYES

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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CHU Côte de Nacre

Caen, , France

Site Status RECRUITING

CH Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

CHU de Bocage Sud

Dijon, , France

Site Status RECRUITING

CHU de La Réunion - Site Sud

La Réunion, , France

Site Status RECRUITING

Groupe Hospitalier de La Rochelle Ré Aunis

La Rochelle, , France

Site Status RECRUITING

Hôtel Dieu

Le Creusot, , France

Site Status NOT_YET_RECRUITING

CHRU de Lille - Hôpital Claude Huriez

Lille, , France

Site Status RECRUITING

AP - HM - Hôpital de la Conception

Marseille, , France

Site Status RECRUITING

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status RECRUITING

CHU de Nantes Hôpital Nord Laennec

Nantes, , France

Site Status RECRUITING

CH Pierre Bérégovoy

Nevers, , France

Site Status RECRUITING

CHU de Nice - Hôpital l'Archet 2

Nice, , France

Site Status RECRUITING

CHU Nîmes - Hôpital universitaire Carémeau

Nîmes, , France

Site Status NOT_YET_RECRUITING

AP-HP - Hôpital Bichat

Paris, , France

Site Status RECRUITING

AP-HP - Hôpital Lariboisière

Paris, , France

Site Status RECRUITING

AP-HP - Hôpital Pitié-Salpétrière

Paris, , France

Site Status RECRUITING

Hôpital Paris Saint Joseph

Paris, , France

Site Status RECRUITING

Hopital Haut-Leveque

Pessac, , France

Site Status RECRUITING

HCL - Hôpital Lyon sud

Pierre-Bénite, , France

Site Status RECRUITING

CHU de la Milétrie

Poitiers, , France

Site Status RECRUITING

CHU de Rouen

Rouen, , France

Site Status RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, , France

Site Status RECRUITING

Maison de Santé Protestante Bagatelle - Hôpital Bagatelle

Talence, , France

Site Status RECRUITING

CHU de Toulouse - Hôpital Rangueil

Toulouse, , France

Site Status RECRUITING

CHU de la Martinique

Fort-de-France, , Martinique

Site Status WITHDRAWN

Countries

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France Martinique

Central Contacts

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Kamel MOHAMMEDI, Pr

Role: CONTACT

Phone: 5 57 65 60 78

Email: [email protected]

Vincent RIGALLEAU, Pr

Role: CONTACT

Email: [email protected]

Facility Contacts

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Yves REZNIK, Pr

Role: primary

Dured DARDARI, Dr

Role: primary

Benjamin BOUILLET, Dr

Role: primary

Estelle NOBECOURT, Dr

Role: primary

Didier GOUET, Dr

Role: primary

Sylvaine CLAVEL, Dr

Role: primary

Florence BAUDOUX, Dr

Role: primary

René VALERO, Pr

Role: primary

Ariane SULTAN, Pr

Role: primary

Samy HADJADJ, Pr

Role: primary

Ardina DESPLAN, Dr

Role: primary

Nicolas CHEVALIER, Dr

Role: primary

Sophie SCHULDINER, Dr

Role: primary

Ronan ROUSSEL, Pr

Role: primary

Jean-François GAUTIER, Pr

Role: primary

Agnès HARTEMANN, Pr

Role: primary

Olivier DUPUY, Dr

Role: primary

MOHAMMEDI Kamel, Pr

Role: primary

Julien VOUILLARMET, Dr

Role: primary

TORREMOCHA Florence, Dr

Role: primary

Gaëtan PREVOST, Pr

Role: primary

Lyse BORDIER, Pr

Role: primary

Pascal TOUSSAINT, Dr

Role: primary

Pierre GOURDY, Pr

Role: primary

Other Identifiers

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CHUBX 2019/70

Identifier Type: -

Identifier Source: org_study_id