Clinical Trial Information

Description of Trial:

A Phase IIb Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Repeat Dose, Multi-Site Study Investigating the Safety, Tolerability, and Efficacy of Personalized Phage Treatment and Standard of Care Antimicrobials for Patients with Diabetic Foot Osteomyelitis due to S. aureus

Protocol Number: APT.DFI.001

Synopsis: This trial is for patients with diabetes who have a foot ulcer/sore/wound and have been told they may have osteomyelitis or bone infection. Approximately 60% of diabetic foot ulcers become infected resulting in a significant risk for hospitalization, surgery and amputation. The longer a wound is open, the greater the risk of bone infection or osteomyelitis. Many diabetic foot ulcers are difficult to heal due to unrecognized or undiagnosed bone infection. In turn this underlying bone infection prevents the wound from healing, while placing the patient at risk for greater complications. In many situations long term antibiotic therapy alone fails approximately 40 to 60% of the time in curing the bone infection. This clinical study is evaluating the use of IV and topically applied bacteriophages to specifically target, attack and kill the staph aureus bacteria in the bone thereby allowing for efficient wound healing. All study related procedures and treatment is at no cost to the patient. Financial compensation for time and travel is offered. Medical/health insurance is not required.

Status: Currently Enrolling Patients