Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

Launched by TECHNOPHAGE, SA · Jul 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TP-102, which is a combination of special viruses known as bacteriophages. These viruses target specific bacteria that can cause infections in diabetic foot wounds. The goal is to see if TP-102 can help heal these wounds when applied directly to the skin every other day, three times a week. This study is currently recruiting participants who are at least 18 years old and have been diagnosed with diabetes. Eligible participants should have a specific type of foot infection that has been present for at least three weeks and meets certain size and depth criteria.

If you decide to participate, you will be monitored closely by the research team to ensure your safety and health throughout the trial. They will assess your wound and may ask for some tests to confirm that the bacteria in your infection can be treated with TP-102. It’s important to know that certain conditions, like having multiple ulcers too close together or being involved in other clinical trials, may prevent you from joining. This study aims to find a new way to help people with difficult-to-treat foot infections, which can be especially serious for individuals with diabetes.

Gender

ALL

Eligibility criteria

• 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.
• Exclusion Criteria:
• • 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.