RecruitingNot ApplicableNCT07161830

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

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

Sponsor

Omeza, LLC

Enrollment

130 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Omeza® Complete Matrix and Standard of Care for people with diabetic foot ulcer. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOmeza® Complete Matrix

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

OTHERStandard of Care

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

Locations(10)

SitePath Research

Evergreen Park, Illinois, United States

MedCentris of Denham Springs

Denham Springs, Louisiana, United States

MedCentris of Leesville

Leesville, Louisiana, United States

MedCentris of Marksville

Marksville, Louisiana, United States

MedCentris of Slidell

Slidell, Louisiana, United States

MedCentris of Vidalia

Vidalia, Louisiana, United States

MedCentris of Cleveland

Cleveland, Mississippi, United States

MedCentris of Southaven

Southaven, Mississippi, United States

Gentle Foot Care

Newark, Ohio, United States

Gentle Foot Care

Sylvania, Ohio, United States

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NCT07161830

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