Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544564
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Human Amniotic Membranes On Venous Leg Ulcers In an Elderly Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-Center Prospective Randomized Trial Evaluating the Efficacy of Human Amniotic Membranes on Venous Leg Ulcers in an Elderly Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 is designed to assess the clinical effectiveness of human amniotic membranes for the management of difficult to heal partial- or full-thickness venous leg ulcers VLUs
Detailed Description:
Multi-center up to 25 sites prospective randomized trial assess the clinical effectiveness of human amniotic membranes for the management of difficult to heal partial- or full-thickness venous leg ulcers VLUs The primary objective is to evaluate the effectiveness of Membrane wrap lite CT Shield Membrane wrap and Membrane wrap hydro versus Standard of Care SOC in subject with eligible venous leg ulcers
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