Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

Eligibility 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.
• * Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
• * Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors;
• * Patient which, in the opinion of the investigator, may not comply with study related procedures;
• * Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion);
• * Being pregnant or breastfeeding;
• * Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP;
• * A condition that, in the opinion of the Investigator, could compromise the well-being of the patient or course of the study, or prevent the patient from meeting or performing any study requirements;
• * Participants with hypersensitivity to any component of investigational products.