OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOmeza, LLC

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

Treatment groups

254 Participants
are divided into 2 treatment groups

Sponsors and collaborators