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

Completed · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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

Key facts

Study ID

NCT05291169

Run by

Omeza, LLC

People needed

54

Starts

2022-04-11

Expected to finish

2024-03-01

Last updated by the study team

2024-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Subject has read and signed the IRB-approved Informed Consent Form before screening procedures are undertakenExclusion Criteria:
• Exclusion
• 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.

Where it is running

• New Hope Podiatry — Los Angeles, California, United States
• Royal Research, Corp — Hollywood, Florida, United States
• Three Rivers Wound and Hyperbaric Center — North Port, Florida, United States
• Wound Care of Tulsa — Tulsa, Oklahoma, United States
• The Foot and Ankle Wellness Center of Western Pennsylvania — Ford City, Pennsylvania, United States
• ACMH Wound Clinic — Kittanning, Pennsylvania, United States
• Serena Group — Monroeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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