Prognostic Determinants in Patients With Diabetic Foot Ulcer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Martinique
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
Overview
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.
Primary outcome measures
- DFU risk score [Time frame: 5 years after inclusion]
Secondary outcome measures (5)
- Survival without active index DFU [Time frame: At 3 and 12 months after inclusion day]
- Survival without recurrent index DFU [Time frame: At 12, 24, 36, 48, 60 months after inclusion day]
- Survival without major adverse limb events (MALE) [Time frame: 5 years after inclusion]
- Survival without major macrovascular events (MACE) [Time frame: 5 years after inclusion]
- Survival without major microvascular events (MICE) [Time frame: 5 years after inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 25 centers
- CHU Côte de Nacre — Caen
- CH Sud Francilien — Corbeil-Essonnes
- CHU de Bocage Sud — Dijon
- CHU de La Réunion - Site Sud — La Réunion
- Groupe Hospitalier de La Rochelle Ré Aunis — La Rochelle
- Hôtel Dieu — Le Creusot
- CHRU de Lille - Hôpital Claude Huriez — Lille
- AP - HM - Hôpital de la Conception — Marseille
- … and 17 more centers
Martinique · 1 center
- CHU de la Martinique — Fort-de-France
Identifiers
NCT: NCT04533152 · CHUBX 2019/70