Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

Inclusion Criteria

• •Aged ≥18 years old;
• •Established diagnosis of Diabetes Mellitus (type I or II);
• •Glycosylated hemoglobin (HbA1c) value \< 12.0%;
• •Designated foot infection meets the following criteria:
• •Present for at least 3 weeks;
• •Below-ankle, full-thickness, cutaneous ulcer;
• •Wound area (after debridement, if applicable) 1 to 20.0 cm2;
• •PEDIS infection grade 2 or 3;
• •PEDIS perfusion grade 1 or 2;
• •PEDIS depth grade 1 or 2 (grade 3 at the discretion of the investigator e.g. if they have received appropriate surgical treatment to remove infected bones).
• •Diabetic foot infection with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to the TP-102 bacteriophage cocktail, as assessed from wound cultures;
• •Patients of suitable physical and mental health as determined by the Investigator on the basis of medical history and general physical examination;
• •Patients of childbearing potential must have a negative serum pregnancy test at screening;
• •ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required in the study and is willing to participate in the study.