OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deborah Klestadt, PhD
- Phone Number: +44 1757 270044
- Email: dklestadt@namsa.com
Study Contact Backup
- Name: Pazely West, BS
- Phone Number: +1 313 473 0569
- Email: pwest@namsa.com
Study Locations
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New York
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Lake Success, New York, United States, 11042
- North Shore University Hospital Wound Care Center and Pain Management Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- 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™
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OCM™ plus Routine Care
Patients will undergo weekly treatments with OCM™ plus compression and routine care. Routine care includes:
|
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:
The routine care intervention will not include treatment with OCM™ and will include:
|
|
Active Comparator: Routine Care
Patients will be treated with compression and routine care only. Routine care includes:
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The routine care intervention will not include treatment with OCM™ and will include:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Ulcer Size
Time Frame: 16 weeks
|
Ulcer size will be measured at end of study.
|
16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alisha Oropallo, MD, Northwell Health Comprehensive Wound Care Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OM-CTP-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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