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The Omeza Protocol for Chronic Ulcers

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ClinicalTrials.gov Identifier: NCT04198441
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Omeza, LLC

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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Diabetic Foot Ulcer Device: Wound dressing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Wound Closure [ Time Frame: 13 weeks ]
    Percent wound closure from baseline

  2. Wound Closure Rate [ Time Frame: 13 weeks ]
    Rate of wound closure measured weekly

  3. Time to Maximum Wound Closure [ Time Frame: 1-13 weeks ]
    Number of weeks to achieve complete wound closure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198441


Contacts
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Contact: Luba Lavrik 561-200-3344 ext 4438 LLavrik@PalmBeachCRO.com

Locations
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United States, Florida
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32256
Contact: Mary Hudson    904-493-3333    mhudson@firstcoastcardio.com   
United States, New Jersey
Saint Michael's Medical Center Recruiting
Newark, New Jersey, United States, 07102
Contact: James Fallon    973-877-2663    JFallon@primehealthcare.com   
United States, Oregon
Oregon Health & Science University (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: David Louie    503-494-6238    louida@ohsu.edu   
United States, Texas
Baylor Scott & White Comprehensive Wound Care Center Recruiting
Dallas, Texas, United States, 75246
Contact: Desirae Ransom, MS,CCRC    214-818-2526    Desirae.Ransom@BSWHealth.org   
Sponsors and Collaborators
Omeza, LLC
Investigators
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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
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Responsible Party: Omeza, LLC
ClinicalTrials.gov Identifier: NCT04198441    
Other Study ID Numbers: Protocol Number: 100
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
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
Additional relevant MeSH terms:
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Diabetic Foot
Varicose Ulcer
Foot Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins