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Virus Therapy

Bacteriophage Therapy for Diabetic Foot Infection (REVERSE2 Trial)

Phase 2
Recruiting
Led By Jose David Suarez
Research Sponsored by Technophage, SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥18 years old
Glycosylated hemoglobin (HbA1c) value < 12.0%
Must not have
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
Timeline
Screening 7 days
Treatment Varies
Follow Up 2 days
Awards & highlights

REVERSE2 Trial Summary

This trial is testing a new topical treatment of wound infections. It's a cocktail of 5 bacteriophages applied TIW to help fight Staph, Pseudomonas, and Acinetobacter.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not detailed here but could include reactions at the application site or allergic responses due to sensitivity to any component of TP-102.

REVERSE2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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Your HbA1c level is less than 12.0%.
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My foot infection has specific characteristics and has lasted for more than 3 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My study ulcer is not near other ulcers by at least 2 cm.
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I am currently receiving treatments like HBOT, NPWT, BES, or growth factors for wound healing.
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I do not have any active tumors, except possibly nonmelanoma skin cancer.

REVERSE2 Trial Timeline

Screening ~ 7 days
Treatment ~ Varies
Follow Up ~2 days
This trial's timeline: 7 days for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. Number and percentage of treatment emergent adverse events (TEAEs)
2. Mean DFUWI score (total AUC) for TP-102 versus Placebo
3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4
Secondary outcome measures
1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo
2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC
3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT;
+1 more

REVERSE2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TP-102Experimental Treatment1 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: PlaceboPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-102
2021
Completed Phase 2
~20

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

VectorB2BUNKNOWN
2 Previous Clinical Trials
35 Total Patients Enrolled
Technophage, SALead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
Jose David SuarezPrincipal InvestigatorKeralty Hospital, Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov displays information that this experiment in question, first advertised on November 8th 2023, is currently looking for participants. In total, the scientific team needs 80 individuals from a single site to particpate.."

Answered by AI

Are there still vacancies available to join this experimental procedure?

"Affirmative, according to the information on clinicaltrials.gov this investigation is currently recruiting individuals for participation. This trial was initially posted on November 8th 2023 and most recently amended on the same date; it aims to enroll 80 applicants from 1 medical centre."

Answered by AI

Has the FDA authorized TP-102 for use?

"Despite lacking evidence for efficacy, the safety profile of TP-102 has been partially validated in a Phase 2 trial and thus receives an estimated rating of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
2023. "Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948592.
~53 spots leftby Apr 2025
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