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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TP-102, which uses bacteriophages (viruses that target bacteria) to address infections in foot wounds caused by diabetes. The aim is to determine if this treatment can effectively combat bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. Participants will receive either the TP-102 treatment or a placebo (a harmless, inactive substance) for comparison. The trial seeks individuals with diabetes who have a persistent foot ulcer infected by these specific bacteria. Participants should not be undergoing advanced treatments like hyperbaric oxygen therapy or have other nearby ulcers. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigators to get a clear answer.

Is there any evidence suggesting that TP-102 is likely to be safe for humans?

Research has shown that TP-102 is safe for treating diabetic foot ulcers. In earlier studies, patients tolerated TP-102 well when applied directly to wounds. No unexpected problems occurred during the treatment. This suggests that the bacteriophage mixture, which targets specific bacteria, could be a promising new treatment for diabetic foot infections. The treatment has proven safe for both infected and uninfected ulcers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diabetic foot infections, which typically include antibiotics, wound care, and sometimes surgery, TP-102 offers a novel approach by utilizing bacteriophage therapy. Bacteriophages are viruses that specifically target and destroy bacteria, potentially reducing infection without harming the body's beneficial bacteria. This unique mechanism could lead to fewer side effects and help combat antibiotic resistance, making researchers particularly excited about TP-102's potential to improve treatment outcomes for patients with diabetic foot infections.

What evidence suggests that TP-102 might be an effective treatment for diabetic foot infection?

Research shows that TP-102, a special mix of viruses targeting bacteria, effectively combats bacteria commonly found in diabetic foot infections, such as Staphylococcus aureus and Pseudomonas aeruginosa. An earlier study demonstrated that TP-102 successfully removed bacteria from diabetic foot sores, suggesting its potential as a promising treatment. Specifically, six patients who used TP-102 had their infections completely cleared, possibly helping them avoid amputation. Another study found that eight patients experienced better outcomes with this treatment, making TP-102 a hopeful new option for managing difficult foot infections in diabetes. This treatment is also considered safe, with no negative side effects reported in the trials. Participants in this trial will receive either TP-102 or a placebo, alongside standard wound care procedures, through random assignment. ^{1 2 3 6 7}

Who Is on the Research Team?

Aman Khanna

Principal Investigator

Aman Hospital & Research Centre

Sanjay Kala

Principal Investigator

GSVM Medical College

Vikas Matai

Principal Investigator

Jupiter Hospital & Research Centre

Sachin Arsule

Principal Investigator

Shree Siddhi Vinayal Hospital

Mohammad Qureshi

Principal Investigator

Crescent Hospital & Heart Centre

Yalamanchi Rao

Principal Investigator

Yalamanchi Hospitals & Research Centers Pvt. Ltd

Abdul Moosa, PI

Principal Investigator

Tranquil Clinical Research

Senthil Kumar

Principal Investigator

MV Hospital for Diabetes Pvt. Ltd

Parikh Niranjan

Principal Investigator

Parikh Multispeciality Healthcare Pvt. Ltd

Stan Mathis, PI

Principal Investigator

Clemente Clinical Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666634024004598

Randomized double-blind study on safety and tolerability ... TP-102 successfully eliminated bacteria infecting diabetic foot ulcers · The bacteriophage mixture was safe with no adverse events reported · TP- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9752496/

1690. Assessing the safety of TP-102 bacteriophage ... TP-102 appeared to be safe when applied to patients with uninfected diabetic foot ulcers. The treatment is a potential new non-traditional antimicrobial for ...

3. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-025-11258-x

Efficacy of phage therapy in Diabetic Foot Ulcers (DFUs) Notably, six patients achieved complete resolution of their infections, likely preventing the need for amputation. In one instance, phage ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04803708?cond=phage%20therapy&rank=8

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers The primary objective of this study is to evaluate the safety of a topical bacteriophage cocktail in the treatment of non infected and infected diabetic foot ...

5. journals.asm.org journals.asm.org/doi/10.1128/jvi.00458-25

Phage therapy: a promising approach for Staphylococcus ... Phage therapy resolved the infection and improved outcomes in eight patients but was unsuccessful in one. DFIs, diabetic foot infections; DFUs, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39740667/

Randomized double-blind study on safety and tolerability ... This randomized double-blind study was conducted to evaluate the safety and tolerability of the TP-102 bacteriophage cocktail in patients with DFUs non- ...

7. cell.com cell.com/med/abstract/S2666-6340(24)00459-8

Randomized double-blind study on safety and tolerability ... TP-102 successfully eliminated bacteria infecting diabetic foot ulcers · The bacteriophage mixture was safe with no adverse events reported · TP- ...