About 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™.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Omeza OCM™ Wound Matrix
- Routine Care