Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT01982318
Status:
WITHDRAWN
Last Update Posted:
2017-05-30
First Post:
2013-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Randomized, Double-Blind, Placebo-Controlled Trial Comparing VitroGro® ECM to Placebo in Patients With Venous Leg Ulcers
Sponsor:
Tissue Therapies Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Multi-Center, Randomized, Double Blind, Placebo-Controlled Trial Comparing Vitrogro® ECM To Placebo As An Adjunct To Standard Care In Patients With Venous Leg Ulcers
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinued. Superseded by NCT02973893 VF00102.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the efficacy and safety of VitroGro® combined with standard care in the treatment of Venous Leg Ulcers (VLUs) compared to Placebo with standard care over the course of the 8-week treatment phase.
Detailed Description:
None
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?: