Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study
This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.
- EligibilityCriteria: Inclusion Criteria:  Type 1 or 2 diabetes Forefoot osteomyelitis Deep tissue infection  Exclusion Criteria:  Pregnancy Severe cognitive impairment Creatinine clearance< 30 ml/min - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult