NCT05177107

Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Adaptive Phage Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2b randomized trial designed to evaluate bacteriophage therapy in subjects with diabetic foot osteomyelitis.

Detailed description

This study will evaluate the safety and efficacy of bacteriophage therapy in subjects with diabetic foot osteomyelitis (DFO). Enrolled subjects will have osteomyelitis infections due to Staph aureus. This study will include eligible subjects who have undergone or are planning to undergo surgical debridement of DFO.

Conditions

• Osteomyelitis
• Diabetic Foot Osteomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Bacteriophage Therapy	Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
OTHER	Placebo	Placebo (normal saline)

Timeline

• Start date: 2021-11-24
• Primary completion: 2025-01-30
• Completion: 2025-05-30
• First posted: 2022-01-04
• Last updated: 2025-08-19

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study