Virus cocktail takes on Antibiotic-Resistant foot infections
NCT ID NCT05948592
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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76 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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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
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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 Hide 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
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Aman Hospital & Research Centre
Vadodara, 390021, India
-
Clemente Clinical Research
Los Angeles, California, 90033, United States
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Crescent Hospital & Heart Centre
Nagpur, 440012, India
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GSVM Medical College
Kanpur, India
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Jupiter Hospital & Research Center
Vadodara, 390012, India
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MV Hospital for Diabetes Pvt. Ltd
Chennai, 600013, India
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Parikh Multispeciality Healthcare Pvt. Ltd
Vadodara, 390020, India
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Shree Siddhi Vinayak Hospital
Nashik, 422002, India
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Tranquil Clinical Research
Webster, Texas, 77598, United States
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Yalamanchi Hospitals & Research Centers Pvt. Ltd
Vijayawada, 520002, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New wound dressing put to the test against diabetic foot ulcers
- Can a united team heal stubborn ulcers faster?
- New antibiotic could be safer for diabetic foot infections
- Bone injection may beat IV for preventing amputation infections in diabetics
- Can a video call heal leg wounds faster? new study tests telemedicine
- New antibiotic could fight tough diabetic foot infections