Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection (NCT05948592) | Clinical Trial Compass
CompletedPhase 2
Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
United States, India76 participantsStarted 2023-11-08
Plain-language summary
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) subst…
What they're measuring
1
1. Number and percentage of treatment emergent adverse events (TEAEs)
Timeframe: From baseline to EOT, aproximately 12 weeks
2
2. Mean DFUWI score (total AUC) for TP-102 versus Placebo
Timeframe: From baseline to EOT, , aproximately 12 weeks
3
3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4