Prognostic Determinants in Patients With Diabetic Foot Ulcer.

Last updated: December 19, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Ulcers

Treatment

N/A

Clinical Study ID

NCT04533152
CHUBX 2019/70
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 currentlyparticipating to another study interfering with standard care of diabetic foot

Study Design

Total Participants: 1000
Study Start date:
November 24, 2021
Estimated Completion Date:
November 30, 2029

Study Description

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.

Connect with a study center

  • CHU Côte de Nacre

    Caen,
    France

    Active - Recruiting

  • CH Sud Francilien

    Corbeil-Essonnes,
    France

    Active - Recruiting

  • CHU de Bocage Sud

    Dijon,
    France

    Active - Recruiting

  • Groupe Hospitalier de La Rochelle Ré Aunis

    La Rochelle,
    France

    Active - Recruiting

  • CHU de La Réunion - Site Sud

    La Réunion,
    France

    Active - Recruiting

  • Hôtel Dieu

    Le Creusot,
    France

    Site Not Available

  • CHRU de Lille - Hôpital Claude Huriez

    Lille,
    France

    Active - Recruiting

  • AP - HM - Hôpital de la Conception

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier,
    France

    Active - Recruiting

  • CHU de Nantes Hôpital Nord Laennec

    Nantes,
    France

    Active - Recruiting

  • CH Pierre Bérégovoy

    Nevers,
    France

    Active - Recruiting

  • CHU de Nice - Hôpital l'Archet 2

    Nice,
    France

    Active - Recruiting

  • CHU Nîmes - Hôpital universitaire Carémeau

    Nîmes,
    France

    Site Not Available

  • AP-HP - Hôpital Bichat

    Paris,
    France

    Active - Recruiting

  • AP-HP - Hôpital Lariboisière

    Paris,
    France

    Active - Recruiting

  • AP-HP - Hôpital Pitié-Salpétrière

    Paris,
    France

    Active - Recruiting

  • Hôpital Paris Saint Joseph

    Paris,
    France

    Active - Recruiting

  • Hopital Haut-Leveque

    Pessac, 33600
    France

    Active - Recruiting

  • HCL - Hôpital Lyon sud

    Pierre-Bénite,
    France

    Active - Recruiting

  • CHU de la Milétrie

    Poitiers, 86021
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé,
    France

    Active - Recruiting

  • Maison de Santé Protestante Bagatelle - Hôpital Bagatelle

    Talence, 33404
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse,
    France

    Active - Recruiting

  • CHU de la Martinique

    Fort de France,
    Martinique

    Site Not Available

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