Programs and studies

Clinical study

REVERSE2

Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

StatusCompleted
TypeTrial
CountriesIndia; Poland; United States
Conditions studiedDiabetic Foot Infection
Study years2023–2025
Entry review2026-10-03

Participation

Check the study record or contact the study team for current recruitment and eligibility.

Study eligibility

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.

Study description

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)).

Study registrations

ClinicalTrials.govNCT05948592
CTIS2023-507716-13-00
Recorded study locations (10)

Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.

Clemente Clinical Research

Los Angeles, California, United States

Recorded site status: Not separately listed. Study location source ↗

Tranquil Clinical Research

Webster, Texas, United States

Recorded site status: Not separately listed. Study location source ↗

MV Hospital for Diabetes Pvt. Ltd

Chennai, India

Recorded site status: Not separately listed. Study location source ↗

GSVM Medical College

Kanpur, India

Recorded site status: Not separately listed. Study location source ↗

Crescent Hospital & Heart Centre

Nagpur, India

Recorded site status: Not separately listed. Study location source ↗

Shree Siddhi Vinayak Hospital

Nashik, India

Recorded site status: Not separately listed. Study location source ↗

Jupiter Hospital & Research Center

Vadodara, India

Recorded site status: Not separately listed. Study location source ↗

Parikh Multispeciality Healthcare Pvt. Ltd

Vadodara, India

Recorded site status: Not separately listed. Study location source ↗

Aman Hospital & Research Centre

Vadodara, India

Recorded site status: Not separately listed. Study location source ↗

Yalamanchi Hospitals & Research Centers Pvt. Ltd

Vijayawada, India

Recorded site status: Not separately listed. Study location source ↗

Related programs(1)

Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

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Study ID
nct05948592