Clinical trial NCT04533152: Prognostic Determinants in Patients With Diabetic Foot Ulcer.
Official title: Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes mellitus
Lower-limb amputation
Wound
Health-related quality of life
Cost-of-illness
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Fondation Francophone pour la Recherche sur le Diabete
First posted: 2020-08-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PDF study is designed to be the first French multicentre, observational and prospective cohort of patients with DFU referred from the community into secondary and tertiary care foot clinics.

Twenty-three French centres agreed to participate in this study. Each centre will recruit during the 3-year inclusion period.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: DFU risk score
timeFrame: 5 years after inclusion
Secondary outcomes:
measure: Survival without active index DFU
timeFrame: At 3 and 12 months after inclusion day
measure: Survival without recurrent index DFU
timeFrame: At 12, 24, 36, 48, 60 months after inclusion day
measure: Survival without major adverse limb events (MALE)
timeFrame: 5 years after inclusion
measure: Survival without major macrovascular events (MACE)
timeFrame: 5 years after inclusion
measure: Survival without major microvascular events (MICE)
timeFrame: 5 years after inclusion
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Côte de Nacre
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Dijon
country: France
facility: CHU de Bocage Sud
city: La Rochelle
country: France
facility: Groupe Hospitalier de La Rochelle Ré Aunis
city: La Réunion
country: France
facility: CHU de La Réunion - Site Sud
city: Le Creusot
country: France
facility: Hôtel Dieu
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Marseille
country: France
facility: AP - HM - Hôpital de la Conception
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nantes
country: France
facility: CHU de Nantes Hôpital Nord Laennec
city: Nevers
country: France
facility: CH Pierre Bérégovoy
city: Nice
country: France
facility: CHU de Nice - Hôpital l'Archet 2
city: Nîmes
country: France
facility: CHU Nîmes - Hôpital universitaire Carémeau
city: Paris
country: France
facility: AP-HP - Hôpital Bichat
city: Paris
country: France
facility: AP-HP - Hôpital Lariboisière
city: Paris
country: France
facility: AP-HP - Hôpital Pitié-Salpétrière
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Pierre-Bénite
country: France
facility: HCL - Hôpital Lyon sud
city: Poitiers
country: France
facility: CHU de la Milétrie
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
city: Talence
country: France
facility: Maison de Santé Protestante Bagatelle - Hôpital Bagatelle
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Rangueil
city: Fort de France
country: Martinique
facility: CHU de la Martinique
Study officials:
affiliation: University Hospital, Bordeaux
name: Nathalie PREAUBERT-HAYES
role: STUDY_CHAIR
References: