Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI · Feb 15, 2024

Keywords

ClinConnect Summary

The BIG D-FOOT Study is a clinical trial that aims to explore the effectiveness and safety of a new treatment for diabetic foot osteomyelitis, which is an infection in the bones of the foot that can occur in people with diabetes. In this study, researchers will compare a special antibiotic treatment delivered directly to the infection site using a biodegradable material to a placebo, which is a similar material without antibiotics. This trial is designed for adults aged 65 to 74 who have type 1 or type 2 diabetes and a specific type of foot infection called forefoot osteomyelitis.

To participate in the study, individuals must have a deep tissue infection related to their diabetes, but those who are pregnant, have severe cognitive issues, or certain kidney problems will not be eligible. Participants can expect to receive either the antibiotic treatment or the placebo and will be monitored closely throughout the trial to assess how well the treatment works and if there are any side effects. This study is not yet recruiting participants, but it represents an important step in finding better treatments for serious foot infections in people with diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Type 1 or 2 diabetes
• • Forefoot osteomyelitis
• • Deep tissue infection
• Exclusion Criteria:
• • Pregnancy
• • Severe cognitive impairment
• • Creatinine clearance\< 30 ml/min