Multifactorial strategies for the prevention of the risks of ulceration in patients affected by diabetic foot: a no-profit, multicentre, clinical trial protocol - PubMed
4 hours ago
- #Diabetic foot
- #Clinical trial
- #Prevention
- The study focuses on preventing diabetic foot ulceration using multifactorial strategies in type-2 diabetes patients.
- It is a no-profit, multicentre clinical trial comparing two groups: those with moderate ulcerative risk (IWGDF grade 2) and those with resolved ulcers (IWGDF grade 3).
- Methods include state-of-the-art clinical, metabolic, biomechanical, and biological analyses, conducted across multiple centres.
- Primary objective is to compare clinical, metabolic, and biomarker profiles between the two groups.
- Secondary objectives include creating a reference database and exploring new biomechanical and biochemical biomarkers.
- Assessments occur at baseline (T0) and 12-month follow-up (T1).
- Ethical approval has been obtained, and results will be shared via publications and conferences.