Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02312518
Status:
UNKNOWN
Last Update Posted:
2021-04-13
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers
Sponsor:
PRP Concepts, LLC
Organization:
Study Overview
Official Title:
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).
Detailed Description:
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing VLU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a VLU (greater than 4 weeks duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: