NCT07161830

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Omeza, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus OCM. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus OCM). Crossover subjects will begin IP arm treatment with weekly OCM applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-04
• Primary completion: 2026-12-01
• Completion: 2027-03-30
• First posted: 2025-09-09
• Last updated: 2025-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study