Clinical study
REVERSE2
Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
| Status | Completed |
|---|---|
| Type | Trial |
| Countries | India; Poland; United States |
| Conditions studied | Diabetic Foot Infection |
| Study years | 2023–2025 |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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.
Study description
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)).
Study registrations
| ClinicalTrials.gov | NCT05948592 |
|---|---|
| CTIS | 2023-507716-13-00 |
Recorded study locations (10)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Clemente Clinical Research
Los Angeles, California, United States
Recorded site status: Not separately listed. Study location source ↗
Tranquil Clinical Research
Webster, Texas, United States
Recorded site status: Not separately listed. Study location source ↗
MV Hospital for Diabetes Pvt. Ltd
Chennai, India
Recorded site status: Not separately listed. Study location source ↗
GSVM Medical College
Kanpur, India
Recorded site status: Not separately listed. Study location source ↗
Crescent Hospital & Heart Centre
Nagpur, India
Recorded site status: Not separately listed. Study location source ↗
Shree Siddhi Vinayak Hospital
Nashik, India
Recorded site status: Not separately listed. Study location source ↗
Jupiter Hospital & Research Center
Vadodara, India
Recorded site status: Not separately listed. Study location source ↗
Parikh Multispeciality Healthcare Pvt. Ltd
Vadodara, India
Recorded site status: Not separately listed. Study location source ↗
Aman Hospital & Research Centre
Vadodara, India
Recorded site status: Not separately listed. Study location source ↗
Yalamanchi Hospitals & Research Centers Pvt. Ltd
Vijayawada, India
Recorded site status: Not separately listed. Study location source ↗
Related programs(1)
TechnoPhage
Provider-listed inquiry route
Recorded program–study link. Website
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct05948592 |
|---|