Prognostic Determinants in Patients With Diabetic Foot Ulcer.

Diabetic Foot Ulcer Clinical Trial

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Official title:

Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533152
• Other study ID #: CHUBX 2019/70
• Status: Recruiting
• Start date: November 24, 2021
• Est. completion date: November 2029

Study information

• Verified date: July 2023
• Source: University Hospital, Bordeaux
• Contact: Kamel MOHAMMEDI, Pr
• Phone: 5 57 65 60 78
• Email: kamel.mohammedi[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Locations

Country	Name	City	State
France	CHU Côte de Nacre	Caen
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	Hôpital d'Instruction des Armées Bégin	Saint-Mandé
France	Maison de Santé Protestante Bagatelle - Hôpital Bagatelle	Talence
France	CHU de Toulouse - Hôpital Rangueil	Toulouse
Martinique	CHU de la Martinique	Fort de France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Fondation Francophone pour la Recherche sur le Diabete

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFU risk score	Construct a DFU risk score equation of all-death will be computed to determine individuals with the higher risk of worse outcomes.	5 years after inclusion
Secondary	Survival without active index DFU		At 3 and 12 months after inclusion day
Secondary	Survival without recurrent index DFU		At 12, 24, 36, 48, 60 months after inclusion day
Secondary	Survival without major adverse limb events (MALE)	MALE is a composite of foot infection, non-traumatic lower-limb amputation (LLA), requirement of revascularization, whichever comes first. These components will be also considered individually.	5 years after inclusion
Secondary	Survival without major macrovascular events (MACE)	MACE is a composite of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death, whichever comes first.	5 years after inclusion
Secondary	Survival without major microvascular events (MICE)	MICE is a composite of new-onset persistent macroalbuminuria, sustained 40% declined eGFR from baseline, ESRD, severe diabetic retinopathy or macular oedema requiring laser photocoagulation or intravitreal therapies, or diabetes-related blindness in either eye, whichever comes first.	5 years after inclusion