Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

NCT05948592 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: TP-102_102
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 10

Brief Summary

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)).

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (3)

• 1. Number and percentage of treatment emergent adverse events (TEAEs)

  See above

  From baseline to EOT, aproximately 12 weeks

• 2. Mean DFUWI score (total AUC) for TP-102 versus Placebo

  See above

  From baseline to EOT, , aproximately 12 weeks

• 3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4

  Week 4

Secondary Outcomes (4)

• 1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo

  From baseline to EOT, , aproximately 12 weeks

• 2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC

  Baseline to EOT, , aproximately 12 weeks

• 3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT;

  EOT, , aproximately 12 weeks

• 4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo at EOT;

  EOT, , aproximately 12 weeks

Study Arms (2)

TP-102

EXPERIMENTAL

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.

Biological: TP-102

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

TP-102 BIOLOGICAL

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).

TP-102

Placebo OTHER

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technophage, SA: lead
• VectorB2B: collaborator

Study Sites (10)

Clemente Clinical Research

Los Angeles, California, 90033, United States

Location

Tranquil Clinical Research

Webster, Texas, 77598, United States

Location

MV Hospital for Diabetes Pvt. Ltd

Chennai, 600013, India

Location

GSVM Medical College

Kanpur, India

Location

Crescent Hospital & Heart Centre

Nagpur, 440012, India

Location

Shree Siddhi Vinayak Hospital

Nashik, 422002, India

Location

Jupiter Hospital & Research Center

Vadodara, 390012, India

Location

Parikh Multispeciality Healthcare Pvt. Ltd

Vadodara, 390020, India

Location

Aman Hospital & Research Centre

Vadodara, 390021, India

Location

Yalamanchi Hospitals & Research Centers Pvt. Ltd

Vijayawada, 520002, India

Location

Study Officials

• Sachin Arsule

  Shree Siddhi Vinayal Hospital

  PRINCIPAL INVESTIGATOR

• Yalamanchi Rao

  Yalamanchi Hospitals & Research Centers Pvt. Ltd

  PRINCIPAL INVESTIGATOR

• Senthil Kumar

  MV Hospital for Diabetes Pvt. Ltd

  PRINCIPAL INVESTIGATOR

• Aman Khanna

  Aman Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

• Mohammad Qureshi

  Crescent Hospital & Heart Centre

  PRINCIPAL INVESTIGATOR

• Parikh Niranjan

  Parikh Multispeciality Healthcare Pvt. Ltd

  PRINCIPAL INVESTIGATOR

• Sanjay Kala

  GSVM Medical College

  PRINCIPAL INVESTIGATOR

• Vikas Matai

  Jupiter Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

• Stan Mathis, PI

  Clemente Clinical Research

  PRINCIPAL INVESTIGATOR

• Abdul Moosa, PI

  Tranquil Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 17, 2023
• Study Start: November 8, 2023
• Primary Completion: October 30, 2025
• Study Completion: December 19, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IN (8)