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Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

NCT04803708 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-04

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • VectorB2B

    collaborator INDUSTRY

  • Technophage, SA

    lead INDUSTRY

Principal Investigators

  • Ran Nir-Paz, MD · Hadassah Medical Organization

  • Ronen Ben Ami, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2022-08-07
Completion
2022-09-05
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803708 on ClinicalTrials.gov