OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.

1. At least 18 years old
2. Women of Childbearing Potential (WOCBP) have a negative Point of Care (POC) urine pregnancy test
3. As of date of randomization, the participant has demonstrated compliance with compression regimen
4. Largest non-healing wound, if multiple wounds are present, or the single wound of interest (Index ulcer) is located between and including the knee and the ankle at or above the malleolus
5. For participants with multiple ulcers, the largest size ulcer will be selected as the Index ulcer
6. There is at least 2cm between the Index ulcer and other ulcers[WS1.1][WS1.2]
7. Index ulcer size is between 1 cm2 and 200 cm2

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

   1. Ankle-Brachial Index (ABI) ≥0.8 and ≤1.3
   2. Toe-Brachial Indx ≥ 0.6
   3. Transcutaneous oxygen pressure (TCOM) ≥40 mmHg
   4. Pulse Volume Recording (PVR): biphasic or triphasic waveforms
9. Confirmation of venous disease by non-invasive venous studies with either Doppler confirmed venous reflux or having ≤2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclerosis, venous dermatitis, atrophie blanch, edema)
10. Willing and able to comply with study procedures, including study visits, compression and study dressing regimens (or have family member/friend willing and able), including ability of the subject to tolerate limb compression bandage.
11. Participant has read and signed the IRB-approved Informed Consent Form (ICF) before screening procedures are undertaken.
12. As of date of randomization, the participant has had routine care and compression for 4 weeks and the participant's VLU has <50% change in measurement
13. The Index ulcer has not been treated with a topical antibiotic within the last 7 days prior to first treatment with OCM™

1. Sensitivity to fish products or cod liver oil allergy[WS2.1][SB2.2] 2. Study ulcer deemed by the investigator to be caused by a medical condition other than venous insufficiency 3. 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* 4. Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration.

5. Study ulcer extends more than 50% below the malleolus 6. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 7. Simultaneous use of more than one product on the Index ulcer 8. Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment 9. The presence of any condition(s) that seriously compromises the subject's ability to complete this study 10. The subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer's etc.) 11. Subjects with a Basic Mass Index (BMI) >65 12. Current, uncontrolled opioid addiction per the investigator's opinion 13. Presence of any monophasic waveforms on segmental Arterial Doppler/Pulse Volume Recording 14. Subject is on Dialysis 15. Any active cancer other than a nonmelanoma skin cancer 16. Any previous cancer in remission for ≤1 year 17. Bone cancer or metastatic disease of the affected limb 18. Chemotherapy within the last 12 months 19. Suspicion of or confirmed malignancy by biopsy within VLU 20. Life expectancy <6 months in the opinion of the Investigator 21. Participant has received a treatment within 28 days of screening which is known to interfere 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 may receive such medications during the screening period, or who has anticipated to require such medication during the study 22. History of immunodeficiency or any illness or condition that could interfere with wound healing:

• Lymphedema
• end-stage renal disease
• severe malnutrition
• liver disease
• aplastic anemia
• Raynaud Syndrome
• connective tissue disorder
• acquired immune deficiency syndrome
• HIV positive
• sickle cell anemia
• Untreated osteomyelitis
• Hepatitis

• Known acute deep venous thrombosis 23. Subject's inability to successfully tolerate compression therapy that is changed weekly 24. All females of childbearing potential who are not using a highly effective method of birth control (failure rate less that 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, practice sexual abstinence or have a vasectomized partner

  • Note: an ulcer that is deemed infected at Screening might be eligible for re-screening once the infection is resolved, at the Investigator's discretion