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Virus cocktail takes on Antibiotic-Resistant foot infections

NCT ID NCT05948592

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a topical treatment called TP-102, a mix of five viruses that target bacteria, in 76 people with diabetic foot infections. The goal was to see if it is safe and helps heal wounds. The treatment is applied directly to the ulcer every other day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TP-102 (a cocktail of 5 viruses that attack bacteria)
What this could lead to
If it works, this could offer a new way to treat diabetic foot infections that are resistant to antibiotics.
What could go wrong
This is a small, early-phase trial focused on safety and wound healing. The treatment may not prove effective, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

Nov 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aman Hospital & Research Centre

    Vadodara, 390021, India

  • Clemente Clinical Research

    Los Angeles, California, 90033, United States

  • Crescent Hospital & Heart Centre

    Nagpur, 440012, India

  • GSVM Medical College

    Kanpur, India

  • Jupiter Hospital & Research Center

    Vadodara, 390012, India

  • MV Hospital for Diabetes Pvt. Ltd

    Chennai, 600013, India

  • Parikh Multispeciality Healthcare Pvt. Ltd

    Vadodara, 390020, India

  • Shree Siddhi Vinayak Hospital

    Nashik, 422002, India

  • Tranquil Clinical Research

    Webster, Texas, 77598, United States

  • Yalamanchi Hospitals & Research Centers Pvt. Ltd

    Vijayawada, 520002, India

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