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

Inclusion Criteria:

1. Subject is at least 18 years old and female subjects are not pregnant

2. Study ulcer has been present for at least 1 month and less than or equal to 12months as of the date the subject signs consent for study

3. Study ulcer size is a minimum of 4.0 cm2 and a maximum of 100.0 cm2

4. The ulcer must be between the knee and ankle, at or above the malleolus, and fullthickness without exposed muscle, tendon, or bone

5. Known HbA1c of < 10% within 3 months

6. Study ulcer may have characteristics that include yellow/white slough with orwithout fibrous/scar tissue and/or non-viable tissue, but not mandatory

7. If more than one ulcer is present on the same leg, they must be greater than 2 cmapart and only the larger ulcer will be included in the study

8. The affected limb must have adequate perfusion confirmed by vascular assessment. Anyof the following methods performed within (1 or 2) months of the first screeningvisit are acceptable:

9. ABI between 0.8 and ≤ 1.3

10. TBI ≥ 0.6

11. TCOM ≥ 40 mmHg

12. PVR: biphasic or triphasic waveforms

13. Subject understands and is willing to participate in the clinical study includingcompression for minimum 14 days (compression dressing changed once weekly) prior tostudy start (see page 23), participate in the informed consent process, and cancomply with weekly visits and the Version 1 Confidential Page 8 of 51 follow-upregimen

14. Willing and able to comply with study procedures, including study visits and studydressing regimens (or have family member/friend willing and able), including abilityof the subject to tolerate limb compression bandage

15. Subject has read and signed the IRB-approved Informed Consent Form before screening

procedures are undertakenExclusion Criteria:

Exclusion

1. Study ulcer deemed by the Investigator to be caused by a medical condition otherthan venous insufficiency.

2. Study ulcer exhibits clinical signs and symptoms of infection, as evidenced bytissue necrosis, redness, pain, and/or purulent drainage and/or receiving systemicantibiotics for the treatment of such

3. Study ulcer is treated with a topical antibiotic during the screening phase.

4. Study ulcer requires enzymatic debridement during the study.

5. Study ulcer has undergone 12 or more months of continuous high-strength compressiontherapy over its duration.

6. Study ulcer is less than 4.0 cm2 or greater than 100.0 cm2 (Determined byMolecuLight Imaging Device).

7. Study ulcer extends more than 50% below the malleolus.

8. Study ulcer has been treated with tissue engineered material (e.g., Apligraf® orDermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem)within the last 30 days.

9. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen duringthe course of the trial.

10. Study ulcer decreases in area by 30% or more during the 14 days screening period.

11. Subjects who are unable to understand the aims and objectives of the trial or have aknown history of poor adherence with medical treatment.

12. Presence of any condition(s) that seriously compromises the subject's ability tocomplete this study.

13. Subjects with a BMI>65

14. Subject is an active smoker

15. Subject has any history of fish allergy or a known sensitivity to any of the SoCmaterials which come into contact with the skin

16. Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3

17. Presence of any monophasic waveforms on segmental Arterial Doppler/Pulse VolumeRecording

18. Subject is on Dialysis

19. Any active cancer other than a nonmelanoma skin cancer; any previous cancer must bein remission for at least 1 year: bone cancer of metastatic disease of the affectedlimb, or has had chemotherapy within the last 12 months

20. Suspicion of malignancy within VLU. Any wound that has been present for > 6 monthsand hasn't previously been biopsied, a biopsy must be performed. Also, if a clinicalsuspicion of malignancy exists in the opinion of the Investigator, a biopsy shouldbe performed regardless of duration of wound.

21. Life expectancy < 6 months

22. Subject has received within 28 days of screening a treatment which is known tointerfere with or affect the rate and quality of wound healing (e.g., thrombolysis,systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis,radiation therapy,chemotherapy, revascularization surgery) to the leg or who mayreceive such medications during the screening period or who has anticipated torequire such medications during the course of the study.

23. History of immunodeficiency or any illness or condition that could interfere withwound healing e.g., lymphedema, end-stage renal disease, severe malnutrition, liverdisease, aplastic anemia. Raynaud's Syndrome, connective tissue disorder, acquiredimmune deficiency syndrome, HIV positive, or sickle cell anemia

24. Untreated osteomyelitis

25. Hepatitis

26. Acute deep venous thrombosis

27. Allergy to lidocaine and/or epinephrine

28. Subject's inability to successfully tolerate compression therapy that is changedweekly

29. All females of childbearing potential who are not using a highly effective method ofbirth control (failure rate less than 1% per year), such as implants, injectables,combined oral contraceptives, some IUDs, practice sexual abstinence or have avasectomized partner.

30. The following are prohibited within 30 days prior to randomized treatment andthroughout the study

31. Heat lamps 2. UV lights 3. Whirlpool baths 4. Hyperbaric oxygen 5. Jet water streams (other than gentle saline irrigation)

*Note: an ulcer that is deemed infected at S1 or TV1 might be eligible for re-screening once the infection is resolved, at the investigator's discretion.