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The Omeza Protocol for Chronic Ulcers

Primary Purpose

Venous Leg Ulcer, Diabetic Foot Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wound dressing

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female 21-80 years of age
Participated in the informed consent process and signed study specific informed consent document
Willing and able to comply with study procedures, including study visits and study dressing regimens
Confirmation of venous disease by non-invasive venous studies with either Doppler- confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema). Biopsy done to exclude other skin conditions e.g. cancer on ulcers ≥ 6 months
HbA1c of ≤ 10%
Have a venous ulcer between the knee and ankle, at or above the malleolus
For VLU's: Target wound size ≥ 4 cm2 to ≤ 150 cm2 in area without exposed tendon, muscle or bone For DFU's: Target wound size ≥ 0.25 cm2 to ≤ 150 cm2 post debridement at Screening Visit and Treatment Visit Week 1/Randomization
Target wound duration of at least 3 months and less than or equal to 12 months as of the date the subject signs consent for study
Containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue
Be willing and able (or have family member/friend willing and able) to apply required dressing changes as well as the ability of the subject to tolerate limb compression bandage
Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3

Exclusion Criteria:

Subjects with a BMI ≥ 65
Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer

Sites / Locations

First Coast Cardiovascular InstituteRecruiting
Saint Michael's Medical CenterRecruiting
Oregon Health & Science University (OHSU)Recruiting
Baylor Scott & White Comprehensive Wound Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Omeza Value-based Bundle Test

Standard Wound Care Control

Arm Description

The Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products.

Standard wound care control is saline wound wash and wet to dry dressing.

Outcomes

Primary Outcome Measures

Wound Closure

Percent wound closure from baseline

Wound Closure Rate

Rate of wound closure measured weekly

Time to Maximum Wound Closure

Number of weeks to achieve complete wound closure

Secondary Outcome Measures

Full Information

NCT ID

NCT04198441

First Posted

December 10, 2019

Last Updated

April 8, 2021

Sponsor

Omeza, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04198441

Brief Title

The Omeza Protocol for Chronic Ulcers

Official Title

A Randomized, Multicenter, Open Label Study Comparing the Omeza® Products Bundle to Standard of Care for Chronic Venous Leg Ulcers and Chronic Diabetic Foot Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 2, 2020 (Actual)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Omeza, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

This is a randomized, multi-center, open-label study comparing the Omeza® Products Bundle versus standard of care treatments for 2 different types of chronic ulcers (venous leg ulcers and diabetic foot ulcers). The treatment period will be 12 weeks, with subjects coming into the study site weekly for evaluations, photography and formal measurements of the target wound, and dressing changes. There will be a total of 13 study site visits. The Screening Visit (Day 0) will occur 1 week prior to randomization and will include routine labs and vascular assessment to determine inclusion/exclusion of the potential subject from the study; followed by weekly treatment visits (Week 1 through Week 11); randomization will occur at Treatment Visit Week 1; the Treatment Visit Week 12/End of Study Visit will include end of study labs. Target wounds will be photographed and measured, and vascular assessment will be done at each of the 13 visits. If the wound closes before Week 12, the subject will continue to come in for all the remaining study visits until study completion. If the wound does not close by Week 12, the subject will be immediately exited from the study and no further follow-up will occur as part of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer, Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omeza Value-based Bundle Test

Arm Type

Active Comparator

Arm Description

The Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products.

Arm Title

Standard Wound Care Control

Arm Type

Active Comparator

Arm Description

Standard wound care control is saline wound wash and wet to dry dressing.

Intervention Type

Device

Intervention Name(s)

Wound dressing

Intervention Description

Clean wound, fill wound, dress wound

Primary Outcome Measure Information:

Title

Wound Closure

Description

Percent wound closure from baseline

Time Frame

13 weeks

Title

Wound Closure Rate

Description

Rate of wound closure measured weekly

Time Frame

13 weeks

Title

Time to Maximum Wound Closure

Description

Number of weeks to achieve complete wound closure

Time Frame

1-13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female 21-80 years of age Participated in the informed consent process and signed study specific informed consent document Willing and able to comply with study procedures, including study visits and study dressing regimens Confirmation of venous disease by non-invasive venous studies with either Doppler- confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema). Biopsy done to exclude other skin conditions e.g. cancer on ulcers ≥ 6 months HbA1c of ≤ 10% Have a venous ulcer between the knee and ankle, at or above the malleolus For VLU's: Target wound size ≥ 4 cm2 to ≤ 150 cm2 in area without exposed tendon, muscle or bone For DFU's: Target wound size ≥ 0.25 cm2 to ≤ 150 cm2 post debridement at Screening Visit and Treatment Visit Week 1/Randomization Target wound duration of at least 3 months and less than or equal to 12 months as of the date the subject signs consent for study Containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue Be willing and able (or have family member/friend willing and able) to apply required dressing changes as well as the ability of the subject to tolerate limb compression bandage Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3 Exclusion Criteria: Subjects with a BMI ≥ 65 Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luba Lavrik

Phone

561-200-3344

Ext

4438

LLavrik@PalmBeachCRO.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew J Applewhite, MD,CWSP,FUHM

Organizational Affiliation

Baylor University Medical Center's Comprehensive Wound Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Swain, DPM,CWSP

Organizational Affiliation

First Coast Cardiovascular Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert B McLafferty, MD,MBA,FACS

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jacob Reinkraut, DPM,FACFAS

Organizational Affiliation

Saint Michael's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Coast Cardiovascular Institute

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Hudson

Phone

904-493-3333

mhudson@firstcoastcardio.com

Facility Name

Saint Michael's Medical Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James Fallon

Phone

973-877-2663

JFallon@primehealthcare.com

Facility Name

Oregon Health & Science University (OHSU)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Louie

Phone

503-494-6238

louida@ohsu.edu

Facility Name

Baylor Scott & White Comprehensive Wound Care Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Desirae Ransom, MS,CCRC

Phone

214-818-2526

Desirae.Ransom@BSWHealth.org

12. IPD Sharing Statement

Learn more about this trial

The Omeza Protocol for Chronic Ulcers

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