Venous Leg Ulcer (VLU)NCT07754526
OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.
A study testing Omeza OCM™ Wound Matrix and Routine Care in people with Venous Leg Ulcer (VLU), run by Omeza, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- Omeza OCM™ Wound Matrix and Routine Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- At least 18 years old
- Women of Childbearing Potential (WOCBP) have a negative Point of Care (POC) urine pregnancy test
- As of date of randomization, the participant has demonstrated compliance with compression regimen
- 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
- For participants with multiple ulcers, the largest size ulcer will be selected as the Index ulcer
- There is at least 2cm between the Index ulcer and other ulcers[WS1.1][WS1.2]
- Index ulcer size is between 1 cm2 and 200 cm2
- 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:
- Ankle-Brachial Index (ABI) ≥0.8 and ≤1.3
- Toe-Brachial Indx ≥ 0.6
- Transcutaneous oxygen pressure (TCOM) ≥40 mmHg
- Pulse Volume Recording (PVR): biphasic or triphasic waveforms
- 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)
- 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.
- Participant has read and signed the IRB-approved Informed Consent Form (ICF) before screening procedures are undertaken.
- 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
- The Index ulcer has not been treated with a topical antibiotic within the last 7 days prior to first treatment with OCM™
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
North Shore University Hospital Wound Care Center and Pain Management Center
Lake Success, New York, 11042
About this study
Official title: A Multicenter, Randomized, Controlled, Open Label Study Comparing Treatment With OCM™️ Plus Compression and Routine Care, to Compression and Routine Care Alone for Venous Leg Ulcers
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™.
Read the detailed description
Chronic venous leg ulcers have a significant impact on the health and quality of life of patients. This burden extends to healthcare systems and society. Underlying comorbidities that predispose patients to chronic wounds can complicate the treatment and assessment of venous leg ulcers. Wound care is dependent on the body's ability to effectively execute a healing process.
Standard treatment of chronic lower extremity ulcers or skin loss (e.g., Venous Leg Ulcers) primarily includes:
- Managing edema with limb elevation and compression, mechanical offloading
- Managing infection with debridement of necrotic or infected tissue
- Managing concomitant and inciting medical issues (blood glucose control, tobacco use)
- Appropriate wound dressing to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization The Omeza Complete Matrix (OCM™) (K211972; September 1, 2021) is a one-time use drug/device cleared by the FDA, indicated for the management of wounds including venous leg ulcers (VLU). This study is a controlled clinical investigation of participants who are treated with the most current and best routine wound care, compared to the wound healing outcomes of participants who receive the same routine care and in addition, treatments of the device used according to its labeled indication. The study data is being used to support payor reimbursement discussions.
OCM™ is a wound care drug-device comprised of a matrix of fish peptides infused with cod liver oil which acts as a protectant. When applied to the wound, the matrix is naturally incorporated into the wound over time to optimize the environment for the natural healing process. While not a skin substitute, OCM™ qualifies as a covered benefit as Physician's services (§ 1861(s)(1)) and incident to a physician's professional services (§ 1861(s)(2)(A)).The study Primary Outcome is modeled after professional practice guidelines and the CMS priority to see evidence of improved outcomes for their beneficiaries. The goal of this study is to demonstrate that OCM with compression and routine care will enable VLUs on an improved healing trajectory over 12 weeks of treatment compared to treatment with compression and routine care only.
- Conditions
- Venous Leg Ulcer (VLU)
- Being tested
- Omeza OCM™ Wound Matrix, Routine Care
- Keywords
- VLU, Chronic Wound, OCM™, Multimodal Wound Matrix
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeza OCM™ Wound MatrixDevice
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.
Routine CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ulcer Size
Ulcer size will be measured at end of study.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alisha Oropallo, MD, Principal investigator, Northwell Health Comprehensive Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754526
- Sponsor's protocol ID
- OM-CTP-004
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open Label Study Comparing Treatment With OCM™️ Plus Compression and Routine Care, to Compression and Routine Care Alone for Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT07754526
- Acronym / sponsor ID
- OM-CTP-004
- Conditions
- Venous Leg Ulcer (VLU)
- Keywords
- VLU, Chronic Wound, OCM™, Multimodal Wound Matrix
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™.
Detailed description
Chronic venous leg ulcers have a significant impact on the health and quality of life of patients. This burden extends to healthcare systems and society. Underlying comorbidities that predispose patients to chronic wounds can complicate the treatment and assessment of venous leg ulcers. Wound care is dependent on the body's ability to effectively execute a healing process.
Standard treatment of chronic lower extremity ulcers or skin loss (e.g., Venous Leg Ulcers) primarily includes:
- Managing edema with limb elevation and compression, mechanical offloading
- Managing infection with debridement of necrotic or infected tissue
- Managing concomitant and inciting medical issues (blood glucose control, tobacco use)
- Appropriate wound dressing to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization The Omeza Complete Matrix (OCM™) (K211972; September 1, 2021) is a one-time use drug/device cleared by the FDA, indicated for the management of wounds including venous leg ulcers (VLU). This study is a controlled clinical investigation of participants who are treated with the most current and best routine wound care, compared to the wound healing outcomes of participants who receive the same routine care and in addition, treatments of the device used according to its labeled indication. The study data is being used to support payor reimbursement discussions.
OCM™ is a wound care drug-device comprised of a matrix of fish peptides infused with cod liver oil which acts as a protectant. When applied to the wound, the matrix is naturally incorporated into the wound over time to optimize the environment for the natural healing process. While not a skin substitute, OCM™ qualifies as a covered benefit as Physician's services (§ 1861(s)(1)) and incident to a physician's professional services (§ 1861(s)(2)(A)).The study Primary Outcome is modeled after professional practice guidelines and the CMS priority to see evidence of improved outcomes for their beneficiaries. The goal of this study is to demonstrate that OCM with compression and routine care will enable VLUs on an improved healing trajectory over 12 weeks of treatment compared to treatment with compression and routine care only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCM™ plus Routine Care | Experimental | Device: Omeza OCM™ Wound Matrix, Procedure: Routine CarePatients 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. |
| Routine Care | Active comparator | Procedure: Routine CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeza OCM™ Wound MatrixAll 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. | Device | OCM™ plus Routine Care |
| Routine CareThe 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. | Procedure or surgery | OCM™ plus Routine Care, Routine Care |
Primary outcome
Change in Ulcer Size
Time frame: 16 weeks
Ulcer size will be measured at end of study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alisha Oropallo, MD principal investigator
Northwell Health Comprehensive Wound Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeza OCM™ Wound Matrix and Routine Care in people with Venous Leg Ulcer (VLU), run by Omeza, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Klestadt, PhD (+44 1757 270044, dklestadt@namsa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ulcer Size (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.