Comparing Bioactive Glass S53P4 and Standard Surgery for Treating Diabetic Foot Bone Infection in the Forefoot

What this Trial Is About

Researchers are evaluating the management of acute and chronic osteomyelitis in patients with diabetic foot syndrome, focusing on infections localized in the forefoot. This prospective multicenter randomized trial compares the effectiveness and safety of a bioactive glass device S53P4 against standard surgical care practices. The goal is to assess healing rates and other outcomes related to bone infection treatment in specialized centers. Participants are randomly assigned to one of two groups. Group A receives surgical removal of the infected bone and soft tissue debridement, along with systemic antibiotics and optional bone substitutes except bioactive glasses. Group B undergoes similar debridement but preserves the bone cortex while replacing infected soft bone with the S53P4 bioactive glass according to its approved use. Both groups aim for primary wound closure and may have vacuum drainage placed postoperatively. Participants are followed closely after surgery with biweekly visits up to three months or until healing, and then at six and twelve months. Assessments include wound evaluation, x-rays, histopathology, laboratory tests, and quality of life and foot function questionnaires. Researchers monitor healing progression, complications such as reinfection, recurrence rates, and functional recovery. The primary outcome is the healing rate at six months, with additional measures including antibiotic duration, re-interventions, amputations, and surgery characteristics.

RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)