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Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers

NCT05291169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-06-06

No results posted yet for this study

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

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Omeza® OCM™

Omeza® OCM™ is a wound care matrix comprised of coldwater fish peptides (device) and cod liver oil (drug). OCM™is supplied in a sterile single use vial.

Sponsors & Collaborators

  • Omeza, LLC

    lead INDUSTRY

Principal Investigators

  • Thomas Serena, MD, FACS · SerenaGroup, Inc.

  • Desmond Bell, DPM · Omeza, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-11-30
Completion
2024-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291169 on ClinicalTrials.gov