The Omeza Protocol for Chronic Ulcers

NCT04198441 | Unknown FDA Device

• 1 other identifier: Protocol Number: 100
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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.

Conditions

Venous Leg Ulcer; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Omeza Value-based Bundle Test

ACTIVE COMPARATOR

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

Device: Wound dressing

Standard Wound Care Control

ACTIVE COMPARATOR

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

Device: Wound dressing

Interventions

Wound dressing DEVICE

Clean wound, fill wound, dress wound

Omeza Value-based Bundle Test; Standard Wound Care Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (4)

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

RECRUITING

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

RECRUITING

Baylor Scott & White Comprehensive Wound Care Center

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Interventions

Bandages

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luba Lavrik

CONTACT

561-200-3344; LLavrik@PalmBeachCRO.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: June 2, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

US (4)