Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:39 PM
Study NCT ID:
NCT04902651
Status:
TERMINATED
Last Update Posted:
2022-07-19
First Post:
2021-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HM242-Gel vs Comparator
Sponsor:
B. Braun Ltd. Centre of Excellence Infection Control
Organization:
Study Overview
Official Title:
A PROSPECTIVE, CONTROLLED, RANDOMIZED, OPEN-LABEL PREMARKET MULTICENTER STUDY OF THE PERFORMANCE OF THE HM242-GEL VS COMPARATOR IN PATIENTS UNDER THE CONDITION OF VENOUS LEG ULCER
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
stopped for futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: