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Recruiting Observational

Prognostic Determinants in Patients With Diabetic Foot Ulcer.

NCT04533152 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-11-24
Last updated
2026-01-15

Condition(s) studied

Diabetic Foot Ulcer

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (26)

FacilityCityRegionStatus
CHU Côte de Nacre Caen France Recruiting
CH Sud Francilien Corbeil-Essonnes France Recruiting
CHU de Bocage Sud Dijon France Recruiting
CHU de La Réunion - Site Sud La Réunion France Recruiting
Groupe Hospitalier de La Rochelle Ré Aunis La Rochelle France Recruiting
Hôtel Dieu Le Creusot France Not Yet Recruiting
CHRU de Lille - Hôpital Claude Huriez Lille France Recruiting
AP - HM - Hôpital de la Conception Marseille France Recruiting
CHU de Montpellier - Hôpital Lapeyronie Montpellier France Recruiting
CHU de Nantes Hôpital Nord Laennec Nantes France Recruiting
CH Pierre Bérégovoy Nevers France Recruiting
CHU de Nice - Hôpital l'Archet 2 Nice France Recruiting
CHU Nîmes - Hôpital universitaire Carémeau Nîmes France Not Yet Recruiting
AP-HP - Hôpital Bichat Paris France Recruiting
AP-HP - Hôpital Lariboisière Paris France Recruiting
AP-HP - Hôpital Pitié-Salpétrière Paris France Recruiting
Hôpital Paris Saint Joseph Paris France Recruiting
Hopital Haut-Leveque Pessac France Recruiting
HCL - Hôpital Lyon sud Pierre-Bénite France Recruiting
CHU de la Milétrie Poitiers France Recruiting
CHU de Rouen Rouen France Recruiting
Centre Hospitalier Saint Benoit Saint-Benoît France Recruiting
Hôpital d'Instruction des Armées Bégin Saint-Mandé France Recruiting
Maison de Santé Protestante Bagatelle - Hôpital Bagatelle Talence France Recruiting
CHU de Toulouse - Hôpital Rangueil Toulouse France Recruiting
CHU de la Martinique Fort-de-France Martinique Withdrawn
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04533152 on ClinicalTrials.gov ↗ ← All trials in France