Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270946
Status:
COMPLETED
Last Update Posted:
2005-12-29
First Post:
2005-12-28
Brief Title:
Evaluation of Bilayered Cellular Matrix OrCel for the Treatment of Venous Ulcers
Sponsor:
Ortec International
Organization:
Ortec International
Study Overview
Official Title:
A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix OrCel for the Treatment of Venous Ulcers
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers OrCel and standard care were compared to standard care alone Standard care consisted of currently accepted compression therapy
Patients were treated for 12 weeks Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound
Patients were treated for 12 weeks Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound
Detailed Description:
None
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