Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2020-06-02
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Omeza Value-based Bundle Test
The Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products.
Wound dressing
Clean wound, fill wound, dress wound
Standard Wound Care Control
Standard wound care control is saline wound wash and wet to dry dressing.
Wound dressing
Clean wound, fill wound, dress wound
Interventions
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Wound dressing
Clean wound, fill wound, dress wound
Eligibility Criteria
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Inclusion Criteria
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
2. Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer
21 Years
80 Years
ALL
No
Sponsors
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Omeza, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew J Applewhite, MD,CWSP,FUHM
Role: PRINCIPAL_INVESTIGATOR
Baylor University Medical Center's Comprehensive Wound Center
David Swain, DPM,CWSP
Role: PRINCIPAL_INVESTIGATOR
First Coast Cardiovascular Institute
Robert B McLafferty, MD,MBA,FACS
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Jacob Reinkraut, DPM,FACFAS
Role: PRINCIPAL_INVESTIGATOR
Saint Michael's Medical Center
Locations
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First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Baylor Scott & White Comprehensive Wound Care Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Protocol Number: 100
Identifier Type: -
Identifier Source: org_study_id
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