Prognostic Determinants in Patients With Diabetic Foot Ulcer.
1 other identifier
observational
1,000
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
January 15, 2026
January 1, 2026
7.9 years
August 27, 2020
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Survival without major macrovascular events (MACE)
5 years after inclusion
Survival without major microvascular events (MICE)
5 years after inclusion
Eligibility Criteria
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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
CHU Côte de Nacre
Caen, France
CH Sud Francilien
Corbeil-Essonnes, 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, 33600, France
HCL - Hôpital Lyon sud
Pierre-Bénite, France
CHU de la Milétrie
Poitiers, 86021, France
CHU de Rouen
Rouen, France
Centre Hospitalier Saint Benoit
Saint-Benoît, 97470, France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, France
Maison de Santé Protestante Bagatelle - Hôpital Bagatelle
Talence, 33404, France
CHU de Toulouse - Hôpital Rangueil
Toulouse, France
CHU de la Martinique
Fort-de-France, Martinique
Biospecimen
1 PAXgene blood DNA tube (2.5 mL)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2020
First Posted
August 31, 2020
Study Start
November 24, 2021
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
January 15, 2026
Record last verified: 2026-01