Prognostic Determinants in Patients With Diabetic Foot Ulcer.

Recruiting

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT04533152
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-31
• Study Start: 2021-11-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DFU risk score	5 years after inclusion	Construct a DFU risk score equation of all-death will be computed to determine individuals with the higher risk of worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Survival without active index DFU	At 3 and 12 months after inclusion day
Survival without recurrent index DFU	At 12, 24, 36, 48, 60 months after inclusion day
Survival without major adverse limb events (MALE)	5 years after inclusion	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.
Survival without major macrovascular events (MACE)	5 years after inclusion	MACE is a composite of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death, whichever comes first.
Survival without major microvascular events (MICE)	5 years after inclusion	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.

Trial Locations

Locations (25)

CHU Côte de Nacre; 🇫🇷 Caen, France

CH Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

CHU de Bocage Sud; 🇫🇷 Dijon, France

Groupe Hospitalier de La Rochelle Ré Aunis; 🇫🇷 La Rochelle, France

CHU de La Réunion - Site Sud; 🇫🇷 La Réunion, 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

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