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

NCT07161830 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

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

Sponsors & Collaborators

  • SygNola, LLC

    collaborator INDUSTRY

  • Omeza, LLC

    lead INDUSTRY

Principal Investigators

  • Angelina Ferguson, DNP · SygNola, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2026-12-01
Completion
2027-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07161830 on ClinicalTrials.gov