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RECRUITING
NCT07161830
NA

Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers

Sponsor: Omeza, LLC

View on ClinicalTrials.gov

Summary

This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.

Official title: Evaluation of the Efficacy of Omeza® Complete Matrix in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-12-04

Completion Date

2027-03-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DEVICE

Omeza® Complete Matrix

OCM Application, Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

OTHER

Standard of Care

Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Locations (3)

MedCentris of Denham Springs

Denham Springs, Louisiana, United States

MedCentris of Leesville

Leesville, Louisiana, United States

MedCentris of Southaven

Southaven, Mississippi, United States