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Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omeza® Collagen Matrix
Sponsored by
Omeza, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is at least 18 years old and female subjects are not pregnant
  2. Study ulcer has been present for at least 1 month and less than or equal to 12 months as of the date the subject signs consent for study
  3. Study ulcer size is a minimum of 4.0 cm2 and a maximum of 100.0 cm2
  4. The ulcer must be between the knee and ankle, at or above the malleolus, and full thickness without exposed muscle, tendon, or bone
  5. Known HbA1c of < 10% within 3 months
  6. Study ulcer may have characteristics that include yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue, but not mandatory
  7. If more than one ulcer is present on the same leg, they must be greater than 2 cm apart and only the larger ulcer will be included in the study
  8. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within (1 or 2) months of the first screening visit are acceptable:

    1. ABI between 0.8 and ≤ 1.3
    2. TBI ≥ 0.6
    3. TCOM ≥ 40 mmHg
    4. PVR: biphasic or triphasic waveforms
  9. Subject understands and is willing to participate in the clinical study including compression for minimum 14 days (compression dressing changed once weekly) prior to study start (see page 23), participate in the informed consent process, and can comply with weekly visits and the Version 1 Confidential Page 8 of 51 follow-up regimen
  10. Willing and able to comply with study procedures, including study visits and study dressing regimens (or have family member/friend willing and able), including ability of the subject to tolerate limb compression bandage
  11. Subject has read and signed the IRB-approved Informed Consent Form before screening procedures are undertakenExclusion Criteria:

Exclusion

  1. Study ulcer deemed by the Investigator to be caused by a medical condition other than venous insufficiency.
  2. Study ulcer exhibits clinical signs and symptoms of infection, as evidenced by tissue necrosis, redness, pain, and/or purulent drainage and/or receiving systemic antibiotics for the treatment of such
  3. Study ulcer is treated with a topical antibiotic during the screening phase.
  4. Study ulcer requires enzymatic debridement during the study.
  5. Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration.
  6. Study ulcer is less than 4.0 cm2 or greater than 100.0 cm2 (Determined by MolecuLight Imaging Device).
  7. Study ulcer extends more than 50% below the malleolus.
  8. Study ulcer has been treated with tissue engineered material (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem) within the last 30 days.
  9. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
  10. Study ulcer decreases in area by 30% or more during the 14 days screening period.
  11. Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment.
  12. Presence of any condition(s) that seriously compromises the subject's ability to complete this study.
  13. Subjects with a BMI>65
  14. Subject is an active smoker
  15. Subject has any history of fish allergy or a known sensitivity to any of the SoC materials which come into contact with the skin
  16. Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3
  17. Presence of any monophasic waveforms on segmental Arterial Doppler/Pulse Volume Recording
  18. Subject is on Dialysis
  19. Any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 1 year: bone cancer of metastatic disease of the affected limb, or has had chemotherapy within the last 12 months
  20. Suspicion of malignancy within VLU. Any wound that has been present for > 6 months and hasn't previously been biopsied, a biopsy must be performed. Also, if a clinical suspicion of malignancy exists in the opinion of the Investigator, a biopsy should be performed regardless of duration of wound.
  21. Life expectancy < 6 months
  22. Subject has received within 28 days of screening a treatment which is known to interfere with or affect the rate and quality of wound healing (e.g., thrombolysis, systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy,chemotherapy, revascularization surgery) to the leg or who may receive such medications during the screening period or who has anticipated to require such medications during the course of the study.
  23. History of immunodeficiency or any illness or condition that could interfere with wound healing e.g., lymphedema, end-stage renal disease, severe malnutrition, liver disease, aplastic anemia. Raynaud's Syndrome, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia
  24. Untreated osteomyelitis
  25. Hepatitis
  26. Acute deep venous thrombosis
  27. Allergy to lidocaine and/or epinephrine
  28. Subject's inability to successfully tolerate compression therapy that is changed weekly
  29. All females of childbearing potential who are not using a highly effective method of birth control (failure rate less than 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, practice sexual abstinence or have a vasectomized partner.
  30. The following are prohibited within 30 days prior to randomized treatment and throughout the study

1. Heat lamps 2. UV lights 3. Whirlpool baths 4. Hyperbaric oxygen 5. Jet water streams (other than gentle saline irrigation)

*Note: an ulcer that is deemed infected at S1 or TV1 might be eligible for re-screening once the infection is resolved, at the investigator's discretion.

Sites / Locations

  • New Hope PodiatryRecruiting
  • Podiatric Surgical SpecialistRecruiting
  • ACMH Wound ClinicRecruiting
  • Serena GroupRecruiting
  • The Serena Group AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Omeza Combination Therapy + SOC

SOC

Arm Description

The Omeza Combination Therapy under investigation includes two Over the Counter (OTC) drugs, Omeza®Lidocaine Lavage for periwound preparation and pain control, and Omeza® Skin Protectant to be applied to the skin from knee to ankle for increased perfusion. Omeza® Collagen Matrix is an FDA cleared 510(K) medical device which is applied directly to the wound bed. The combination treatment is applied on a weekly basis, followed by compression management

Cleaning and debriding the Study ulcers and compression management on a weekly basis.

Outcomes

Primary Outcome Measures

To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers
To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers through SAE/AE reporting
To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care
To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care by Wound measurements using the MolecuLight Imaging Device
To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline
To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline based on wounds measurements using the MolecuLight Imaging Device

Secondary Outcome Measures

Change in the subjects' Quality of Life (QoL) a. week to week using a numerical scale b. reported pain perception c. assessment of drainage d. enhanced activities in daily living
Change in the subjects' Quality of Life (QoL) using the PEG scale which is a validated pain scoring system. It consists of three 1-10 rating scales: numerical, enjoyment of life and general activity. The subject indicates a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "Pain as bad as you can imagine" on the right side of the number line.

Full Information

First Posted
March 2, 2022
Last Updated
June 19, 2023
Sponsor
Omeza, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05291169
Brief Title
Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers
Official Title
A Randomized, Multicenter, Open Label Study Comparing Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
September 21, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Randomized, Multicenter, Open Label Study Comparing Omeza Combination Therapy with Standard of Care to Standard of Care alone for Chronic Venous Leg Ulcers over the course of 4 weeks
Detailed Description
The study will have three phases: Screening, Treatment and Healing Confirmation. The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. At or up to 14 days before the first Screening Phase Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.At the first Screening Phase Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer. Subjects whose target ulcer has been treated with compression therapy for the previous two weeks are eligible to enter the treatment phase once all of the inclusion and exclusion criteria are met. Note: if the target ulcer has not received any high-strength compression, the subject must be placed into compression for a minimum of 14 days prior to enrollment (run-in phase). The Treatment Phase (TV1 to TV4) begins with a series of assessments designed to confirm the subject's continued eligibility. Subjects whose ulcers continue to meet eligibility criteria will then be randomized to one of two groups: (1) Omeza Combination Therapy (a lidocaine based periulcer preparation, a collagen-based topical treatment, and a periwound protectant) plus Standard of Care; or (2) Standard of Care (multiple layered compression therapy) alone. At the conclusion of the 4-week treatment visits, enrolled Subjects will have the option to continue receiving Omeza Combination Therapy and Standard of Care protocol up to an additional 8 weeks. Assessments will be taken and further therapy for the Subject will be at the PI's discretion.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized to Omeza Combination therapy and SOC Vs SOC alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omeza Combination Therapy + SOC
Arm Type
Experimental
Arm Description
The Omeza Combination Therapy under investigation includes two Over the Counter (OTC) drugs, Omeza®Lidocaine Lavage for periwound preparation and pain control, and Omeza® Skin Protectant to be applied to the skin from knee to ankle for increased perfusion. Omeza® Collagen Matrix is an FDA cleared 510(K) medical device which is applied directly to the wound bed. The combination treatment is applied on a weekly basis, followed by compression management
Arm Title
SOC
Arm Type
No Intervention
Arm Description
Cleaning and debriding the Study ulcers and compression management on a weekly basis.
Intervention Type
Device
Intervention Name(s)
Omeza® Collagen Matrix
Intervention Description
Omeza® Collagen Matrix is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular and irregular wound beds, to provide a conducive environment for the patient's natural wound healing process. Contains: Fish collagen, cod liver oil, medium chain triglyceride oil, coconut oil, hemp seed oil, triethyl citrate, ethyl linoleate, caprylic acid, red palm concentrate, monolaurin, cetyl esters NF, beeswax, ascorbyl palmitate, sea salt Omeza® Collagen Matrix is supplied in a sterile single use vial.
Primary Outcome Measure Information:
Title
To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers
Description
To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers through SAE/AE reporting
Time Frame
12 weeks
Title
To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care
Description
To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care by Wound measurements using the MolecuLight Imaging Device
Time Frame
4 weeks
Title
To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline
Description
To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline based on wounds measurements using the MolecuLight Imaging Device
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in the subjects' Quality of Life (QoL) a. week to week using a numerical scale b. reported pain perception c. assessment of drainage d. enhanced activities in daily living
Description
Change in the subjects' Quality of Life (QoL) using the PEG scale which is a validated pain scoring system. It consists of three 1-10 rating scales: numerical, enjoyment of life and general activity. The subject indicates a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "Pain as bad as you can imagine" on the right side of the number line.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in bacterial fluorescence using the MolecuLight device at baseline and weekly.
Description
Change in bacterial fluorescence using the MolecuLight device at baseline and weekly at their weekly treatment visits
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 years old and female subjects are not pregnant Study ulcer has been present for at least 1 month and less than or equal to 12 months as of the date the subject signs consent for study Study ulcer size is a minimum of 4.0 cm2 and a maximum of 100.0 cm2 The ulcer must be between the knee and ankle, at or above the malleolus, and full thickness without exposed muscle, tendon, or bone Known HbA1c of < 10% within 3 months Study ulcer may have characteristics that include yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue, but not mandatory If more than one ulcer is present on the same leg, they must be greater than 2 cm apart and only the larger ulcer will be included in the study The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within (1 or 2) months of the first screening visit are acceptable: ABI between 0.8 and ≤ 1.3 TBI ≥ 0.6 TCOM ≥ 40 mmHg PVR: biphasic or triphasic waveforms Subject understands and is willing to participate in the clinical study including compression for minimum 14 days (compression dressing changed once weekly) prior to study start (see page 23), participate in the informed consent process, and can comply with weekly visits and the Version 1 Confidential Page 8 of 51 follow-up regimen Willing and able to comply with study procedures, including study visits and study dressing regimens (or have family member/friend willing and able), including ability of the subject to tolerate limb compression bandage Subject has read and signed the IRB-approved Informed Consent Form before screening procedures are undertakenExclusion Criteria: Exclusion Study ulcer deemed by the Investigator to be caused by a medical condition other than venous insufficiency. Study ulcer exhibits clinical signs and symptoms of infection, as evidenced by tissue necrosis, redness, pain, and/or purulent drainage and/or receiving systemic antibiotics for the treatment of such Study ulcer is treated with a topical antibiotic during the screening phase. Study ulcer requires enzymatic debridement during the study. Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration. Study ulcer is less than 4.0 cm2 or greater than 100.0 cm2 (Determined by MolecuLight Imaging Device). Study ulcer extends more than 50% below the malleolus. Study ulcer has been treated with tissue engineered material (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem) within the last 30 days. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial. Study ulcer decreases in area by 30% or more during the 14 days screening period. Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment. Presence of any condition(s) that seriously compromises the subject's ability to complete this study. Subjects with a BMI>65 Subject is an active smoker Subject has any history of fish allergy or a known sensitivity to any of the SoC materials which come into contact with the skin Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3 Presence of any monophasic waveforms on segmental Arterial Doppler/Pulse Volume Recording Subject is on Dialysis Any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 1 year: bone cancer of metastatic disease of the affected limb, or has had chemotherapy within the last 12 months Suspicion of malignancy within VLU. Any wound that has been present for > 6 months and hasn't previously been biopsied, a biopsy must be performed. Also, if a clinical suspicion of malignancy exists in the opinion of the Investigator, a biopsy should be performed regardless of duration of wound. Life expectancy < 6 months Subject has received within 28 days of screening a treatment which is known to interfere with or affect the rate and quality of wound healing (e.g., thrombolysis, systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy,chemotherapy, revascularization surgery) to the leg or who may receive such medications during the screening period or who has anticipated to require such medications during the course of the study. History of immunodeficiency or any illness or condition that could interfere with wound healing e.g., lymphedema, end-stage renal disease, severe malnutrition, liver disease, aplastic anemia. Raynaud's Syndrome, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia Untreated osteomyelitis Hepatitis Acute deep venous thrombosis Allergy to lidocaine and/or epinephrine Subject's inability to successfully tolerate compression therapy that is changed weekly All females of childbearing potential who are not using a highly effective method of birth control (failure rate less than 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, practice sexual abstinence or have a vasectomized partner. The following are prohibited within 30 days prior to randomized treatment and throughout the study 1. Heat lamps 2. UV lights 3. Whirlpool baths 4. Hyperbaric oxygen 5. Jet water streams (other than gentle saline irrigation) *Note: an ulcer that is deemed infected at S1 or TV1 might be eligible for re-screening once the infection is resolved, at the investigator's discretion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Moore, BSN,MBE
Phone
786-371-6184
Email
smoore@serenagroups.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kristy Breisinger, BS
Phone
412-212-0123
Email
kbreisinger@serenagroups.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Serena, MD, FACS
Organizational Affiliation
SerenaGroup, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Hope Podiatry
City
Los Angeles
State/Province
California
ZIP/Postal Code
90063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Morfin
Phone
323-264-6157
Email
francis_morfin@yahoo.com
First Name & Middle Initial & Last Name & Degree
Demitric Lopez
Phone
323-264-6157
Email
demetriclopez@gmail.com
First Name & Middle Initial & Last Name & Degree
Charles Ananian, DPM
Facility Name
Podiatric Surgical Specialist
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa Llupi
Phone
586-260-9941
Email
ellupi@hfhs.org
First Name & Middle Initial & Last Name & Degree
Brian Loder, DPM
Facility Name
ACMH Wound Clinic
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Schrecengost
Phone
724-664-3843
First Name & Middle Initial & Last Name & Degree
Brian Doner, DO
Facility Name
Serena Group
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Serena, LPN
Phone
412-212-0123
Email
lserena@serenagroups.com
First Name & Middle Initial & Last Name & Degree
Keyur D Patel, DO
Facility Name
The Serena Group Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendell Rodriguez
Phone
888-960-1343
Ext
1015
Email
krodriguez@serenagroups.com
First Name & Middle Initial & Last Name & Degree
Taylor Yardley

12. IPD Sharing Statement

Plan to Share IPD
No

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Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers

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