The Omeza Protocol for Chronic Ulcers

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer
• Intervention / Treatment: Device: Wound dressing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luba Lavrik; Phone Number: 4438 561-200-3344; Email: LLavrik@PalmBeachCRO.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • First Coast Cardiovascular Institute
      • Contact: Mary Hudson; Phone Number: 904-493-3333; Email: mhudson@firstcoastcardio.com
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Recruiting
      • Saint Michael's Medical Center
      • Contact: James Fallon; Phone Number: 973-877-2663; Email: JFallon@primehealthcare.com
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University (OHSU)
      • Contact: David Louie; Phone Number: 503-494-6238; Email: louida@ohsu.edu
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Comprehensive Wound Care Center
      • Contact: Desirae Ransom, MS,CCRC; Phone Number: 214-818-2526; Email: Desirae.Ransom@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female 21-80 years of age
2. Participated in the informed consent process and signed study specific informed consent document
3. Willing and able to comply with study procedures, including study visits and study dressing regimens
4. 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
5. HbA1c of ≤ 10%
6. Have a venous ulcer between the knee and ankle, at or above the malleolus
7. 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
8. 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
9. Containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue
10. 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
11. Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Omeza Value-based Bundle Test; The Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products.	Device: Wound dressing; Clean wound, fill wound, dress wound
ACTIVE_COMPARATOR: Standard Wound Care Control; Standard wound care control is saline wound wash and wet to dry dressing.	Device: Wound dressing; Clean wound, fill wound, dress wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Closure	Percent wound closure from baseline	13 weeks
Wound Closure Rate	Rate of wound closure measured weekly	13 weeks
Time to Maximum Wound Closure	Number of weeks to achieve complete wound closure	1-13 weeks

Collaborators and Investigators

• Sponsor: Omeza, LLC
• Investigators: Principal Investigator: Andrew J Applewhite, MD,CWSP,FUHM, Baylor University Medical Center's Comprehensive Wound Center; Principal Investigator: David Swain, DPM,CWSP, First Coast Cardiovascular Institute; Principal Investigator: Robert B McLafferty, MD,MBA,FACS, Oregon Health and Science University; Principal Investigator: Jacob Reinkraut, DPM,FACFAS, Saint Michael's Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: Protocol Number: 100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes