OCM™ for Venous Leg Ulcers
What You Need to Know Before You Apply
What is the purpose of this trial?
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™.
Who Is on the Research Team?
Alisha Oropallo, MD
Principal Investigator
Northwell Health Comprehensive Wound Care Center
Are You a Good Fit for This Trial?
This trial is for people with venous leg ulcers (open sores on the legs caused by poor blood flow). Participants should be able to receive standard wound care and compression therapy. People with other types of wounds or health issues that could interfere with healing may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Omeza OCM™ Wound Matrix
Trial Overview
The study compares two treatments: one group gets a new product called Omeza OCM™ Wound Matrix along with routine care and compression, while the other group receives only routine care and compression. The goal is to see if adding OCM™ helps wounds heal better.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Omeza, LLC
Lead Sponsor
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