COMPLETED

Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)).

Official Title

A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI

Quick Facts

Study Start:2023-11-08

Study Completion:2025-12-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05948592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Sachin Arsule

PRINCIPAL_INVESTIGATOR

Shree Siddhi Vinayal Hospital

Yalamanchi Rao

PRINCIPAL_INVESTIGATOR

Yalamanchi Hospitals & Research Centers Pvt. Ltd

Senthil Kumar

PRINCIPAL_INVESTIGATOR

MV Hospital for Diabetes Pvt. Ltd

Aman Khanna

PRINCIPAL_INVESTIGATOR

Aman Hospital & Research Centre

Mohammad Qureshi

PRINCIPAL_INVESTIGATOR

Crescent Hospital & Heart Centre

Parikh Niranjan

PRINCIPAL_INVESTIGATOR

Parikh Multispeciality Healthcare Pvt. Ltd

Sanjay Kala

PRINCIPAL_INVESTIGATOR

GSVM Medical College

Vikas Matai

PRINCIPAL_INVESTIGATOR

Jupiter Hospital & Research Centre

Stan Mathis, PI

PRINCIPAL_INVESTIGATOR

Clemente Clinical Research

Abdul Moosa, PI

PRINCIPAL_INVESTIGATOR

Tranquil Clinical Research

Study Locations (Sites)

Clemente Clinical Research

Los Angeles, California, 90033

United States

Tranquil Clinical Research

Webster, Texas, 77598

United States

Collaborators and Investigators

Sponsor: Technophage, SA

Sachin Arsule, PRINCIPAL_INVESTIGATOR, Shree Siddhi Vinayal Hospital
Yalamanchi Rao, PRINCIPAL_INVESTIGATOR, Yalamanchi Hospitals & Research Centers Pvt. Ltd
Senthil Kumar, PRINCIPAL_INVESTIGATOR, MV Hospital for Diabetes Pvt. Ltd
Aman Khanna, PRINCIPAL_INVESTIGATOR, Aman Hospital & Research Centre
Mohammad Qureshi, PRINCIPAL_INVESTIGATOR, Crescent Hospital & Heart Centre
Parikh Niranjan, PRINCIPAL_INVESTIGATOR, Parikh Multispeciality Healthcare Pvt. Ltd
Sanjay Kala, PRINCIPAL_INVESTIGATOR, GSVM Medical College
Vikas Matai, PRINCIPAL_INVESTIGATOR, Jupiter Hospital & Research Centre
Stan Mathis, PI, PRINCIPAL_INVESTIGATOR, Clemente Clinical Research
Abdul Moosa, PI, PRINCIPAL_INVESTIGATOR, Tranquil Clinical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2025-12-19

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2025-12-19

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Foot Infection