NCT04803708

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

A Double-Blind and Randomized Study to Determine the Safety and Tolerability of Multiple Doses of TP-102 in Subjects With Non-Infected and Infected Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Technophage, SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

Detailed description

The primary objective of this study is to evaluate the safety of a topical bacteriophage cocktail in the treatment of non infected and infected diabetic foot ulcers with Pseudomonas aeruginosa, Staphylococcus aureus and/or Acinetobacter baumanni. Patients will also be evaluated for bacterial clearance and wound reduction.

Conditions

• Diabetic Foot Ulcer
• Pseudomonas Aeruginosa Infection
• Staphylococcus Aureus Infection
• Acinetobacter Infection

Interventions

Type	Name	Description
BIOLOGICAL	TP-102	One mL of IP solution will be applied topically per cm3 of target ulcer. The titer of each bacteriophage in TP 102 is 1x10\^9 plaque forming units per milliliter (PFU/mL).

Timeline

• Start date: 2021-03-22
• Primary completion: 2022-08-07
• Completion: 2022-09-05
• First posted: 2021-03-18
• Last updated: 2022-10-04

Locations

2 sites across 1 country: Israel

Regulatory

• FDA-regulated drug study