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™.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
254
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.
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.
North Shore University Hospital Wound Care Center and Pain Management Center
Lake Success, New York, United States
Change in Ulcer Size
Ulcer size will be measured at end of study.
Time frame: 16 weeks
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