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
Omeza, LLC
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™.
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 debridem…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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\[WS1.1\]\[WS1.2\]…
Interventions
- DeviceOmeza OCM™ Wound Matrix
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.
- ProcedureRoutine Care
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.
Location
- North Shore University Hospital Wound Care Center and Pain Management CenterLake Success, New York