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

NCT07754526 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: OM-CTP-004
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the use of OCM™ for the treatment of vascular leg ulcers (VLUs). The study seeks to evaluate the results of treating VLUs with OCM™ plus routine care and compression for complete wound healing; ability of the patient to return to previous function and resume normal activity, and reduction in the size of the wound. The results will be compared to patients who undergo routine care and compression without OCM™.

Conditions

Venous Leg Ulcer (VLU)

Keywords

VLU; Chronic Wound; OCM™; Multimodal Wound Matrix

Outcome Measures

Primary Outcomes (1)

• Change in Ulcer Size

  Ulcer size will be measured at end of study.

  16 weeks

Study Arms (2)

OCM™ plus Routine Care

EXPERIMENTAL

Patients will undergo weekly treatments with OCM™ plus compression and routine care. Routine care includes: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycemic control * Revascularization if deemed clinically necessary * Continued close observation.

Device: Omeza OCM™ Wound Matrix; Procedure: Routine Care

Routine Care

ACTIVE COMPARATOR

Patients will be treated with compression and routine care only. Routine care includes: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycaemic control * Revascularization if deemed clinically necessary * Continued close observation.

Procedure: Routine Care

Interventions

Omeza OCM™ Wound Matrix DEVICE

All patients participating in the study will be treated with compression and routine care. The patients in the experimental arm will also be treated with the OCM™ Wound Matrix. Routine wound care will include: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycaemic control * Revascularization if deemed clinically necessary * Continued close observation.

OCM™ plus Routine Care

Routine Care PROCEDURE

The routine care intervention will not include treatment with OCM™ and will include: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycaemic control * Revascularization if deemed clinically necessary * Continued close observation.

OCM™ plus Routine Care; Routine Care

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (1)

North Shore University Hospital Wound Care Center and Pain Management Center

Lake Success, New York, 11042, 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

• Alisha Oropallo, MD

  Northwell Health Comprehensive Wound Care Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Klestadt, PhD

CONTACT

+44 1757 270044; dklestadt@namsa.com

Pazely West, BS

CONTACT

+1 313 473 0569; pwest@namsa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent Blinded Assessor of digital images
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)