RecruitingNot Applicable

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

United States130 participantsStarted 2025-12-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or Female, 18 years of age or older
. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
. Index ulcer is a minimum of 0.7cm2 and a maximum of 25cm2 at first treatment visit
. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization

Exclusion criteria

. Subject has a known life expectance of \<1 year

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Wound Closure

Timeframe: 1-12 weeks

Trial details

NCT IDNCT07161830

SponsorOmeza, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Angelina Ferguson, DNP

9866294013 dr.aferguson@sygnola.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials