Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803708
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2021-03-02
Brief Title:
Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers
Sponsor:
Technophage SA
Organization:
Technophage SA
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVERSE
Brief Summary:
This is a Phase IIIa 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 andor Acinetobacter baumanni Patients will also be evaluated for bacterial clearance and wound reduction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None