Prognostic Determinants in Patients With Diabetic Foot Ulcer.
Prognostic Determinants in Patients With Diabetic Foot Ulcer (PDF Cohort) - A French Prospective Multicentre Cohort.
University Hospital, Bordeaux
1,000 participants
Nov 24, 2021
OBSERVATIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria6
- 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
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Locations(26)
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NCT04533152