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The Omeza Protocol for Chronic Ulcers

NCT04198441 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-04-09

No results posted yet for this study

Summary

This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.

Conditions

  • Venous Leg Ulcer
  • Diabetic Foot Ulcer

Interventions

DEVICE

Wound dressing

Clean wound, fill wound, dress wound

Sponsors & Collaborators

  • Omeza, LLC

    lead INDUSTRY

Principal Investigators

  • Andrew J Applewhite, MD,CWSP,FUHM · Baylor University Medical Center's Comprehensive Wound Center

  • David Swain, DPM,CWSP · First Coast Cardiovascular Institute

  • Robert B McLafferty, MD,MBA,FACS · Oregon Health and Science University

  • Jacob Reinkraut, DPM,FACFAS · Saint Michael's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2021-10-31
Completion
2021-12-31
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 NCT04198441 on ClinicalTrials.gov