NCT04533152 Prognostic Determinants in Patients With Diabetic Foot Ulcer.
| NCT ID | NCT04533152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Diabetic Foot Ulcer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-11-24 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-11-24 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04533152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04533152 currently recruiting?
Yes, NCT04533152 is actively recruiting participants. Contact the research team at kamel.mohammedi@chu-bordeaux.fr for enrollment information.
Where is the NCT04533152 trial being conducted?
This trial is being conducted at Caen, France, Corbeil-Essonnes, France, Dijon, France, La Réunion, France and 11 additional locations.
Who is sponsoring the NCT04533152 clinical trial?
NCT04533152 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 1,000 participants.