Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-07 @ 7:47 PM
Study NCT ID:
NCT05921292
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2023-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies
Sponsor:
Omeza, LLC
Organization:
Study Overview
Official Title:
A Clinical Study to Evaluate the Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies
Status:
COMPLETED
Status Verified Date:
2024-06
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 goal of this clinical trial is to evaluate the use of Omeza combination therapy with Standard of Care. The main question it aims to answer is:
\- Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period?
Patients will be treated with:
* OCM™ Wound Matrix
* Omeza combination therapy
* Standard of Care
\- Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period?
Patients will be treated with:
* OCM™ Wound Matrix
* Omeza combination therapy
* Standard of Care
Detailed Description:
The goal of this clinical trial is to demonstrate that the Omeza combination therapy with Standard of Care supports chronic wounds to move from chronicity to a healing trajectory. The trial is targeting those wounds that have failed therapy prior to trial enrollment and are chronic by definition of no change in area size after 2 weeks of standard of care treatment. The inclusion and exclusion criteria applied to this chronic wound clinical trial is broadened with the intention to include all patients and outliers that would not qualify for controlled trials.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: