Phase 2b Randomized, Parallel, Double-blind, Placebo-Controlled, Repeat Dose, Multi-Site Study for Safety, Tolerability, and Efficacy of Personalized Phage Treatment and SoC for Subjects With Diabetic Foot Osteomyelitis Due to S. Aureus
This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.
• 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