Venous Leg UlcerNCT04198441
The Omeza Protocol for Chronic Ulcers
A study testing Wound dressing in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by Omeza, LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Venous Leg Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jun 2020to Dec 2021
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Baylor Scott & White Comprehensive Wound Care Center
Dallas, Texas, 75246
Desirae Ransom, MS,CCRC, 214-818-2526, Desirae.Ransom@BSWHealth.org
- Recruiting
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Mary Hudson, 904-493-3333, mhudson@firstcoastcardio.com
- Recruiting
Saint Michael's Medical Center
Newark, New Jersey, 07102
James Fallon, 973-877-2663, JFallon@primehealthcare.com
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
David Louie, 503-494-6238, louida@ohsu.edu
About this study
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
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.
Read the 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.
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer
- Being tested
- Wound dressing
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound dressingDevice
Clean wound, fill wound, dress wound
| Study group | Role | What they receive |
|---|---|---|
| Omeza Value-based Bundle Test | Active comparator | The Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products. Receives: Device: Wound dressing |
| Standard Wound Care Control | Active comparator | Standard wound care control is saline wound wash and wet to dry dressing. Receives: Device: Wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Percent wound closure from baseline
Measured: 13 weeks
Wound Closure Rate
Rate of wound closure measured weekly
Measured: 13 weeks
Time to Maximum Wound Closure
Number of weeks to achieve complete wound closure
Measured: 1-13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start2 Jun 2020
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew J Applewhite, MD,CWSP,FUHM, Principal investigator, Baylor University Medical Center's Comprehensive Wound CenterDavid Swain, DPM,CWSP, Principal investigator, First Coast Cardiovascular InstituteRobert B McLafferty, MD,MBA,FACS, Principal investigator, Oregon Health and Science UniversityJacob Reinkraut, DPM,FACFAS, Principal investigator, Saint Michael's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198441
- Sponsor's protocol ID
- Protocol Number: 100
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2019
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04198441
- Acronym / sponsor ID
- Protocol Number: 100
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Dec 2019 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeza Value-based Bundle Test | Active comparator | Device: Wound dressingThe Omeza value-based bundle consists of lidocaine lavage, flowable collagen matrix and skin protectant products. |
| Standard Wound Care Control | Active comparator | Device: Wound dressingStandard wound care control is saline wound wash and wet to dry dressing. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Wound dressingClean wound, fill wound, dress wound | Device | Omeza Value-based Bundle Test, Standard Wound Care Control |
Primary outcome
Wound Closure
Time frame: 13 weeks
Percent wound closure from baseline
Wound Closure Rate
Time frame: 13 weeks
Rate of wound closure measured weekly
Time to Maximum Wound Closure
Time frame: 1-13 weeks
Number of weeks to achieve complete wound closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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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.
Andrew J Applewhite, MD,CWSP,FUHM principal investigator
Baylor University Medical Center's Comprehensive Wound Center
David Swain, DPM,CWSP principal investigator
First Coast Cardiovascular Institute
Robert B McLafferty, MD,MBA,FACS principal investigator
Oregon Health and Science University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound dressing in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by Omeza, LLC at 4 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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luba Lavrik (561-200-3344 ext. 4438, LLavrik@PalmBeachCRO.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 13 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 9 Apr 2021.