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

NCT05291169 | Completed FDA Device

• 1 other identifier: OM-CTP-001.1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 7

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

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (3)

• To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers

  To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers through SAE/AE reporting

  12 weeks

• To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care

  To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care by Wound measurements using the MolecuLight Imaging Device

  4 weeks

• To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline

  To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline based on wounds measurements using the MolecuLight Imaging Device

  4 weeks

Secondary Outcomes (1)

• Change in the subjects' Quality of Life (QoL) a. week to week using a numerical scale b. reported pain perception c. assessment of drainage d. enhanced activities in daily living

  12 weeks

Other Outcomes (1)

• Change in bacterial fluorescence using the MolecuLight device at baseline and weekly.

  12 weeks

Study Arms (2)

OCM™ plus Standard of Care

EXPERIMENTAL

Omeza® OCM™ is an FDA cleared 510(K) medical combination drug/device which is applied directly to the wound bed. Treatment, followed by compression management, is applied on a weekly basis.

Device: Omeza® OCM™

Standard of Care

NO INTERVENTION

Cleaning and debridement of the ulcers with compression management on a weekly basis.

Interventions

Omeza® OCM™ DEVICE

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.

Also known as: Omeza® Complete Matrix, Multimodal Wound Matrix

OCM™ plus Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years old and female subjects are not pregnant
• Study ulcer has been present for at least 1 month and less than or equal to 12 months as of the date the subject signs consent for study
• Study ulcer size is a minimum of 4.0 cm2 and a maximum of 100.0 cm2
• The ulcer must be between the knee and ankle, at or above the malleolus, and full thickness without exposed muscle, tendon, or bone
• Known HbA1c of \< 10% within 3 months
• Study ulcer may have characteristics that include yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue, but not mandatory
• If more than one ulcer is present on the same leg, they must be greater than 2 cm apart and only the larger ulcer will be included in the study
• The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within (1 or 2) months of the first screening visit are acceptable:
• ABI between 0.8 and ≤ 1.3
• TBI ≥ 0.6
• TCOM ≥ 40 mmHg
• PVR: biphasic or triphasic waveforms
• Subject understands and is willing to participate in the clinical study including compression for minimum 14 days (compression dressing changed once weekly) prior to study start (see page 23), participate in the informed consent process, and can comply with weekly visits and the Version 1 Confidential Page 8 of 51 follow-up regimen
• Willing and able to comply with study procedures, including study visits and study dressing regimens (or have family member/friend willing and able), including ability of the subject to tolerate limb compression bandage

You may not qualify if:

• Study ulcer deemed by the Investigator to be caused by a medical condition other than venous insufficiency.
• Study ulcer exhibits clinical signs and symptoms of infection, as evidenced by tissue necrosis, redness, pain, and/or purulent drainage and/or receiving systemic antibiotics for the treatment of such
• Study ulcer is treated with a topical antibiotic during the screening phase.
• Study ulcer requires enzymatic debridement during the study.
• Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration.
• Study ulcer is less than 4.0 cm2 or greater than 100.0 cm2 (Determined by MolecuLight Imaging Device).
• Study ulcer extends more than 50% below the malleolus.
• Study ulcer has been treated with tissue engineered material (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem) within the last 30 days.
• Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
• Study ulcer decreases in area by 30% or more during the 14 days screening period.
• Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment.
• Presence of any condition(s) that seriously compromises the subject's ability to complete this study.
• Subjects with a BMI\>65
• Subject is an active smoker
• Subject has any history of fish allergy or a known sensitivity to any of the SoC materials which come into contact with the skin

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (7)

New Hope Podiatry

Los Angeles, California, 90063, United States

Location

Royal Research, Corp

Hollywood, Florida, 33021, United States

Location

Three Rivers Wound and Hyperbaric Center

North Port, Florida, 34289, United States

Location

Wound Care of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

The Foot and Ankle Wellness Center of Western Pennsylvania

Ford City, Pennsylvania, 16226, United States

Location

ACMH Wound Clinic

Kittanning, Pennsylvania, 16201, United States

Location

Serena Group

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas Serena, MD, FACS

  SerenaGroup, Inc.

  STUDY CHAIR

• Desmond Bell, DPM

  Omeza, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized to Omeza Combination therapy and SOC Vs SOC alone

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 22, 2022
• Study Start: April 11, 2022
• Primary Completion: November 30, 2023
• Study Completion: March 1, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)