MedTrace Logo

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

NCT07754526 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-08-10

No results posted yet for this study

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™.

Conditions

  • Venous Leg Ulcer (VLU)

Interventions

DEVICE

Omeza 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.

PROCEDURE

Routine 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.

Sponsors & Collaborators

  • Omeza, LLC

    lead INDUSTRY

Principal Investigators

  • Alisha Oropallo, MD · Northwell Health Comprehensive Wound Care Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-09-30
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754526 on ClinicalTrials.gov