Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05291169
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2022-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers
Sponsor:
Omeza, LLC
Organization:
Study Overview
Official Title:
A Randomized, Multicenter, Open Label Study Comparing Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers
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:
A Randomized, Multicenter, Open Label Study Comparing Omeza Combination Therapy with Standard of Care to Standard of Care alone for Chronic Venous Leg Ulcers over the course of 4 weeks
Detailed Description:
The study will have three phases: Screening, Treatment and Healing Confirmation.
The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility.
At or up to 14 days before the first Screening Phase Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.At the first Screening Phase Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
Subjects whose target ulcer has been treated with compression therapy for the previous two weeks are eligible to enter the treatment phase once all of the inclusion and exclusion criteria are met. Note: if the target ulcer has not received any high-strength compression, the subject must be placed into compression for a minimum of 14 days prior to enrollment (run-in phase).
The Treatment Phase (TV1 to TV4) begins with a series of assessments designed to confirm the subject's continued eligibility. Subjects whose ulcers continue to meet eligibility criteria will then be randomized to one of two groups: (1) Omeza Combination Therapy (a lidocaine based periulcer preparation, a collagen-based topical treatment, and a periwound protectant) plus Standard of Care; or (2) Standard of Care (multiple layered compression therapy) alone.
At the conclusion of the 4-week treatment visits, enrolled Subjects will have the option to continue receiving Omeza Combination Therapy and Standard of Care protocol up to an additional 8 weeks.
Assessments will be taken and further therapy for the Subject will be at the PI's discretion.
The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility.
At or up to 14 days before the first Screening Phase Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.At the first Screening Phase Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
Subjects whose target ulcer has been treated with compression therapy for the previous two weeks are eligible to enter the treatment phase once all of the inclusion and exclusion criteria are met. Note: if the target ulcer has not received any high-strength compression, the subject must be placed into compression for a minimum of 14 days prior to enrollment (run-in phase).
The Treatment Phase (TV1 to TV4) begins with a series of assessments designed to confirm the subject's continued eligibility. Subjects whose ulcers continue to meet eligibility criteria will then be randomized to one of two groups: (1) Omeza Combination Therapy (a lidocaine based periulcer preparation, a collagen-based topical treatment, and a periwound protectant) plus Standard of Care; or (2) Standard of Care (multiple layered compression therapy) alone.
At the conclusion of the 4-week treatment visits, enrolled Subjects will have the option to continue receiving Omeza Combination Therapy and Standard of Care protocol up to an additional 8 weeks.
Assessments will be taken and further therapy for the Subject will be at the PI's discretion.
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?:
False
Is an FDA AA801 Violation?: