Venous Leg UlcerNCT05291169
Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers
A study testing Omeza® OCM™ in people with Venous Leg Ulcer, run by Omeza, LLC at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Omeza® OCM™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Apr 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, 16226
Royal Research, Corp
Hollywood, Florida, 33021
ACMH Wound Clinic
Kittanning, Pennsylvania, 16201
New Hope Podiatry
Los Angeles, California, 90063
Serena Group
Monroeville, Pennsylvania, 15146
Three Rivers Wound and Hyperbaric Center
North Port, Florida, 34289
Wound Care of Tulsa
Tulsa, Oklahoma, 74135
About this study
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
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
Read the 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Omeza® OCM™
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeza® OCM™Device
Also called Omeza® Complete Matrix, Multimodal Wound Matrix
Omeza® OCM™ is a wound care matrix comprised of coldwater fish peptides (device) and cod liver oil (drug).
OCM™is supplied in a sterile single use vial.
| Study group | Role | What they receive |
|---|---|---|
| OCM™ plus Standard of Care | Experimental | Omeza® OCM™ is an FDA cleared 510(K) medical combination drug/device which is applied directly to the wound bed. Treatment, followed by compression management, is applied on a weekly basis. Receives: Device: Omeza® OCM™ |
| Standard of Care | No intervention | Cleaning and debridement of the ulcers with compression management on a weekly basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start11 Apr 2022
- Primary completion30 Nov 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to Omeza Combination therapy and SOC Vs SOC alone
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, FACS, Study chair, SerenaGroup, Inc.Desmond Bell, DPM, Study director, Omeza, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291169
- Sponsor's protocol ID
- OM-CTP-001.1
- Status last verified
- Jun 2024
- First submitted
- 2 Mar 2022
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05291169
- Acronym / sponsor ID
- OM-CTP-001.1
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized to Omeza Combination therapy and SOC Vs SOC alone
| Arm | Type | Receives |
|---|---|---|
| OCM™ plus Standard of Care | Experimental | Device: Omeza® OCM™Omeza® OCM™ is an FDA cleared 510(K) medical combination drug/device which is applied directly to the wound bed. Treatment, followed by compression management, is applied on a weekly basis. |
| Standard of Care | No intervention | –Cleaning and debridement of the ulcers with compression management on a weekly basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeza® OCM™Also: Omeza® Complete Matrix, Multimodal Wound MatrixOmeza® OCM™ is a wound care matrix comprised of coldwater fish peptides (device) and cod liver oil (drug). OCM™is supplied in a sterile single use vial. | Device | OCM™ plus Standard of Care |
Primary outcome
To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers
Time frame: 12 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline based on wounds measurements using the MolecuLight Imaging Device
1 secondary outcome
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
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Serena, MD, FACS study chair
SerenaGroup, Inc.
Desmond Bell, DPM study director
Omeza, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeza® OCM™ in people with Venous Leg Ulcer, run by Omeza, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.