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 theyhave received appropriate surgical treatment to remove infected bones).

• Diabetic foot infection with at least one target bacterial strain (Pseudomonasaeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to theTP-102 bacteriophage cocktail, as assessed from wound cultures;

• Patients of suitable physical and mental health as determined by the Investigator onthe basis of medical history and general physical examination;

• Patients of childbearing potential must have a negative serum pregnancy test atscreening;

• ICF signed voluntarily before any study-related procedure is performed, indicatingthat the patient understands the purpose of, and procedures required in the studyand is willing to participate in the study.

Exclusion Criteria:

• Infected study ulcer less than 2 cm away from other ulcers, in the case of multipleulcers;

• 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 relatedprocedures;

• Presence of active malignant or benign tumors of any kind, (with exception tononmelanoma skin cancer as per investigator's discretion);

• Being pregnant or breastfeeding;

• Currently participating in another clinical trial or having participated in aprevious clinical trial with receipt of an investigational product within 30 days ofthe first administration of IP;

• A condition that, in the opinion of the Investigator, could compromise thewell-being of the patient or course of the study, or prevent the patient frommeeting or performing any study requirements;

• Participants with hypersensitivity to any component of investigational products.