Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399308
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2006-11-10
Brief Title:
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
An Initial Evaluation Of The Safety And Activity Of CeladermTM Treatment Regimens In Healing Venous Leg Ulcers
Status:
COMPLETED
Status Verified Date:
2021-06
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:
None
Brief Summary:
This pilot study was designed to test the safety of CeladermTM in treating venous leg ulcers and to give preliminary information about the efficacy of two different CeladermTM dosing regimens
Detailed Description:
CeladermTM weekly for four weeks or biweekly for four treatments combined with ProforeR compression vs ProforeR compression alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None