Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

Inclusion Criteria: * Male or female ≥18 to \<85 years of age. * Ongoing diagnosis of diabetes. * Have undergone or are scheduled to undergo surgical debridement for DFO as part of SoC, with the associated bone culture positive for S. aureus * Availability of at least 1 matching phage for S. aureus cultured from the bone culture * Receiving SoC treatment for DFO, including antibiotics after debridement and before randomization * Meet defined study ulcer requirements as defined in the protocol * Adequate circulation to the affected extremity demonstrated within 3 months prior to randomization and no revascularization procedure anticipated * History of compliance with prior appointments and treatments in the investigator's opinion and willingness to receive and comply with SOC antimicrobial and clinical treatments for the study ulcer, including offloading Exclusion Criteria: * Healing of the ulcer by more than 30% between screening and randomization. * Treated with hyperbaric oxygen or cellular/tissue products with 30 days of screening * Suspicion of neoplasm associated with the study ulcer or any non-study diabetic ulcer independent of biopsy result. * Presence of any cellulitis not localized to the study ulcer. * Indwelling hardware at the site of the DFO. * Body weight \<50 kg. * Presence of above ankle ulcer, with \>50% above medial malleolus * Hemoglobin \< 7g/dL * Abnormal liver function tests * History of underlying liver disease at screening or within last 3 months *…