Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
NCT ID: NCT05948592
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2023-11-08
2025-12-19
Brief Summary
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Detailed Description
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Eighty (80) patients with an infected diabetic foot ulcer and with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii) susceptible to TP-102.
Patients will be randomised to receive TP-102 or placebo, in a 1:1 ratio. Patients will be treated with 1 (one) mL of IP/ Placebo solution applied topically per cm3 of target ulcer. Patients will be treated with a total of 12 treatments in 28 days (+3 days) with at least one day of interval in between the days of treatment (no consecutive days of treatment are allowed) and a maximum of 3 (three) days without treatment.
The titre of each bacteriophage in TP-102 is 1x109 (\>1x108 and \< 1x1010) plaque forming units per milliliter (PFU/mL).
Assessments for efficacy and safety will include concomitant medications and AEs, local tolerability, clinical laboratory tests, vital signs, physical examination, wound biopsy/swab to determine the presence, speciation and TP-102 sensitivity of bacteria and target ulcer assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TP-102
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.
TP-102
Patients randomised to TP-102 will receive 1 (one) mL of IP solution, applied topically per cm3 of target ulcer. The titre of each bacteriophage in TP-102 is 1x109 PFU/mL (\>1x108 PFU/mL and \<1x1010 PFU/mL). All patients randomised to TP-102 will receive the same concentration per mL. TP-102 will be applied to the target ulcer using a syringe without a needle. The volume of TP-102 to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
Placebo
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.
Placebo
Patients randomised to placebo, the volume calculated to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
Interventions
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TP-102
Patients randomised to TP-102 will receive 1 (one) mL of IP solution, applied topically per cm3 of target ulcer. The titre of each bacteriophage in TP-102 is 1x109 PFU/mL (\>1x108 PFU/mL and \<1x1010 PFU/mL). All patients randomised to TP-102 will receive the same concentration per mL. TP-102 will be applied to the target ulcer using a syringe without a needle. The volume of TP-102 to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
Placebo
Patients randomised to placebo, the volume calculated to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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VectorB2B
INDUSTRY
Technophage, SA
INDUSTRY
Responsible Party
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Principal Investigators
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Sachin Arsule
Role: PRINCIPAL_INVESTIGATOR
Shree Siddhi Vinayal Hospital
Yalamanchi Rao
Role: PRINCIPAL_INVESTIGATOR
Yalamanchi Hospitals & Research Centers Pvt. Ltd
Senthil Kumar
Role: PRINCIPAL_INVESTIGATOR
MV Hospital for Diabetes Pvt. Ltd
Aman Khanna
Role: PRINCIPAL_INVESTIGATOR
Aman Hospital & Research Centre
Mohammad Qureshi
Role: PRINCIPAL_INVESTIGATOR
Crescent Hospital & Heart Centre
Parikh Niranjan
Role: PRINCIPAL_INVESTIGATOR
Parikh Multispeciality Healthcare Pvt. Ltd
Sanjay Kala
Role: PRINCIPAL_INVESTIGATOR
GSVM Medical College
Vikas Matai
Role: PRINCIPAL_INVESTIGATOR
Jupiter Hospital & Research Centre
Stan Mathis, PI
Role: PRINCIPAL_INVESTIGATOR
Clemente Clinical Research
Abdul Moosa, PI
Role: PRINCIPAL_INVESTIGATOR
Tranquil Clinical Research
Locations
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Clemente Clinical Research
Los Angeles, California, United States
Tranquil Clinical Research
Webster, Texas, United States
MV Hospital for Diabetes Pvt. Ltd
Chennai, , India
GSVM Medical College
Kanpur, , India
Crescent Hospital & Heart Centre
Nagpur, , India
Shree Siddhi Vinayak Hospital
Nashik, , India
Jupiter Hospital & Research Center
Vadodara, , India
Parikh Multispeciality Healthcare Pvt. Ltd
Vadodara, , India
Aman Hospital & Research Centre
Vadodara, , India
Yalamanchi Hospitals & Research Centers Pvt. Ltd
Vijayawada, , India
Countries
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Other Identifiers
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TP-102_102
Identifier Type: -
Identifier Source: org_study_id