Understanding the prognosis of diabetic foot ulcers
Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
This study looks at how long people with diabetic foot ulcers live and what affects their health over five years, while also checking how these ulcers impact their quality of life and healthcare costs in France.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 26 sites (Caen and 25 other locations) |
| Trial ID | NCT04533152 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the 5-year mortality rate and its causes in patients with diabetic foot ulcers (DFU) across multiple centers in France. It seeks to identify relevant prognostic determinants beyond cardiovascular risks, including inflammatory, infectious, and malignant conditions. The study will also assess changes in health-related quality of life and the economic impact of DFU on the French healthcare system using claims databases. Participants will be followed for five years or until death, providing valuable insights into the long-term outcomes of DFU.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with diabetes who have a diabetic foot ulcer measuring at least 5 mm in diameter.
Not a fit: Patients with acute or chronic lower-limb ischemia without an open skin wound or those with foot infections without open skin wounds may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of diabetic foot ulcers, potentially reducing mortality and enhancing quality of life for patients.
How similar studies have performed: While there have been studies on diabetic foot ulcers, this specific approach focusing on a multi-center cohort and comprehensive prognostic determinants is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen and 25 other locations
- 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)
Study contacts
- Study coordinator: Kamel MOHAMMEDI, Pr
- Email: kamel.mohammedi@chu-bordeaux.fr
- Phone: 5 57 65 60 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.