Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04667416
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2020-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
Sponsor:
Amnio Technology, LLC
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of PalinGen® Flow Amniotic Tissue Allograft to Assess Safety, Tolerability, and Preliminary Efficacy for the Treatment of Chronic Lower Extremity Cutaneous Ulcers Compared to Standard of Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: