Understanding the prognosis of diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• CHRU de Lille - Hôpital Claude Huriez
  Lille, France Recruiting

Study contacts

• Study coordinator: Kamel MOHAMMEDI, Pr
• Email: kamel.mohammedi@chu-bordeaux.fr
• Phone: 5 57 65 60 78

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BIOxHEAL plus standard care for nonhealing diabetic foot ulcers

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• L-Carnitine as an add-on for healing diabetic foot ulcers

  This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.

  Recruiting Phase 2 Ain Shams University · Cairo, Cairo Governorate and 1 other locations · NCT07768228

• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

  This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.

  Recruiting Biointelligent Technology Systems SL · Barcelona · NCT07617961

• Pulsating electromagnetic field therapy for diabetic foot ulcers

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• Transverse tibial bone transport to help heal chronic diabetic foot ulcers

  This study tests a surgical approach called transverse tibial bone transport to see if it can help heal long‑lasting diabetic foot ulcers and prevent limb loss in adults with limited treatment options.

  Recruiting Biodynamik, Inc · Jacksonville, Florida · NCT07444593

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.