Bacteriophage Therapy for Diabetic Foot Infection

(REVERSE2 Trial)

Recruiting at 10 trial locations

Overseen By Margarida Barreto, Clinical Trial Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Technophage, SA

Disqualifiers: Tumors, Pregnancy, Other clinical trials, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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)).

Research Team

Stan Mathis, PI

Principal Investigator

Clemente Clinical Research

Abdul Moosa, PI

Principal Investigator

Tranquil Clinical Research

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

Yalamanchi Rao

Principal Investigator

Yalamanchi Hospitals & Research Centers Pvt. Ltd

Sachin Arsule

Principal Investigator

Shree Siddhi Vinayal Hospital

Parikh Niranjan

Principal Investigator

Parikh Multispeciality Healthcare Pvt. Ltd

Sanjay Kala

Principal Investigator

GSVM Medical College

Vikas Matai

Principal Investigator

Jupiter Hospital & Research Centre

Eligibility Criteria

Adults over 18 with diabetes and a specific type of long-lasting foot infection can join this trial. Their blood sugar levels should be reasonably controlled (HbA1c < 12.0%). The infection must meet certain criteria, including size and severity, and respond to the TP-102 bacteriophage cocktail. Pregnant or breastfeeding individuals, those in other trials recently, or with conditions that may interfere with the study cannot participate.

Inclusion Criteria

Patients of suitable physical and mental health as determined by the Investigator

Women who could become pregnant must have a negative pregnancy test before joining the study.

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

My study ulcer is not near other ulcers by at least 2 cm.

I do not have any active tumors, except possibly nonmelanoma skin cancer.

I am currently receiving treatments like HBOT, NPWT, BES, or growth factors for wound healing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TP-102 or placebo applied topically every other day for 28 days

4 weeks

12 treatments over 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• TP-102

Trial Overview The trial is testing TP-102, a mix of viruses targeting bacteria causing foot infections in diabetics. It's applied topically every other day against a placebo to see if it helps heal chronic ulcers better by killing off specific bacteria.

Participant Groups

Group I: TP-102 Experimental Treatment 1 Intervention

Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine.

Group II: Placebo Placebo Group 1 Intervention

Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine.

Who Is Running the Clinical Trial?

Technophage, SA

Lead Sponsor

Trials

4

Recruited

140+

VectorB2B

Industry Sponsor

VectorB2B

Collaborator

Trials

4

Recruited

140+