Diabetic Foot UlcerNCT07161830
Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
A study testing Omeza® Complete Matrix in people with Diabetic Foot Ulcer, run by Omeza, LLC at 10 sites in United States.
Trial summary
This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Omeza® Complete Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 10 sitesUnited States
- Study dates
- 4 Dec 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
- Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record) and being treated with continuous SOC
- Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
- Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
- Subject has a diabetic foot ulcer of Wagner grade 1 or 2
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- Index ulcer is a minimum of 0.7cm2 and a maximum of 25cm2 at first treatment visit
- Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization
- Adequate circulation of ulcer demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
- Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.
- Index ulcer is free of necrotic debris prior to OCMTM application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
Who cannot join
- Subject has a known life expectance of <1 year
- Subject is unable to comply with protocol treatment
- Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
- Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
- Known contraindications to fish products or cod liver oil.
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- Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and/or healing
- Subject is pregnant or breastfeeding
- Subject with history of immunosuppressant treatment (systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for >2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 14 days prior to randomization
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
MedCentris of Cleveland
Cleveland, Mississippi, 38732
Paige Livingston, courtney.livingston@medcentris.com
Shauna Allen, FNP
- Recruiting
MedCentris of Denham Springs
Denham Springs, Louisiana, 70726
Tabatha Yent, LPN, Tabatha.yent@medcentris.com
Monique Consoer, NP
- Recruiting
SitePath Research
Evergreen Park, Illinois, 60805
Ana Petrovic, apetrovic@sitepathresearch.com
Bela Pandit, DPM
- Recruiting
MedCentris of Leesville
Leesville, Louisiana, 71446
Brandi Shuff, LPN, Brandi.shuff@medcentris.com
Stefanie Corley, NP
- Recruiting
MedCentris of Marksville
Marksville, Louisiana, 71351
Laura Whittington, laura.whittington@medcentris.com
Averie Rachal, NP
- Recruiting
Gentle Foot Care
Newark, Ohio, 43055
Mandy Wilson, awilson@ohiofootspecialists.com
Jeffrey Wilson, DPM
- Recruiting
MedCentris of Slidell
Slidell, Louisiana, 70458
Donyille Singletary, RN, donyille.singletary@medcentris.com
Natalie Dean, FNP
- Recruiting
MedCentris of Southaven
Southaven, Mississippi, 38671
Juliase Walls, LPN, juliase.walls@medcentris.com
Carlene McAllister, NP
- Recruiting
Gentle Foot Care
Sylvania, Ohio, 43560
Betsy Naugle, bmn1016@gmail.com
Gregory Black, DPM
- Recruiting
MedCentris of Vidalia
Vidalia, Louisiana, 71373
Taylor Estis, taylor.estis@medcentris.com
Shanda Jackson, NP
About this study
Official title: Evaluation of the Efficacy of Omeza® Complete Matrix in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial
This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.
Read the detailed description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus OCM. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus OCM). Crossover subjects will begin IP arm treatment with weekly OCM applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Omeza® Complete Matrix, Standard of Care
- Keywords
- Chronic Wounds, Wound Medicine
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeza® Complete MatrixDevice
Also called OCM
OCM Application, Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance
Standard of CareOther
Also called SOC
Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance
| Study group | Role | What they receive |
|---|---|---|
| OCM + SOC | Experimental | Omeza® Complete Matrix (OCM™) is a wound care matrix comprised of fish peptides infused with cod liver oil that functions as an anhydrous skin protectant, along with other plant-derived oils, waxes, and sea salt. Receives: Device: Omeza® Complete Matrix |
| Standard of Care | Active comparator | Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks.
Measured: 1-12 weeks
Secondary outcomes (2)
Percentage Wound Area Change
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.
Measured: 1-12 weeks
Pain Assessment
Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale throughout the study. The Numeric Pain Rating Scale is measured between 0-10. 0 being no pain at all and 10 being the worst pain.
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start4 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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
- The subject will be randomized to one of the following treatments: * Standard of care * OCM in addition to standard of care
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Responsible party
- Sponsor
- Investigators
- Angelina Ferguson, DNP, Study director, SygNola, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161830
- Sponsor's protocol ID
- Ocdiam
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2025
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Omeza® Complete Matrix in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial
- ClinicalTrials.gov ID
- NCT07161830
- Acronym / sponsor ID
- Ocdiam
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Chronic Wounds, Wound Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SygNola, LLC
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Sep 2025 (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 aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.
Detailed description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus OCM. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus OCM). Crossover subjects will begin IP arm treatment with weekly OCM applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subject will be randomized to one of the following treatments: * Standard of care * OCM in addition to standard of care
| Arm | Type | Receives |
|---|---|---|
| OCM + SOC | Experimental | Device: Omeza® Complete MatrixOmeza® Complete Matrix (OCM™) is a wound care matrix comprised of fish peptides infused with cod liver oil that functions as an anhydrous skin protectant, along with other plant-derived oils, waxes, and sea salt. |
| Standard of Care | Active comparator | Other: Standard of CareSurgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
- Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record) and being treated with continuous SOC
- Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
- Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
Key exclusion criteria (14 listed)
- Subject has a known life expectance of <1 year
- Subject is unable to comply with protocol treatment
- Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
- Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
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® Complete MatrixAlso: OCMOCM Application, Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance | Device | OCM + SOC |
| Standard of CareAlso: SOCSurgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance | Other | Standard of Care |
Primary outcome
Complete Wound Closure
Time frame: 1-12 weeks
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks.
2 secondary outcomes
Percentage Wound Area Change
Time frame: 1-12 weeks
Pain Assessment
Time frame: 1-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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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.
Angelina Ferguson, DNP study director
SygNola, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeza® Complete Matrix in people with Diabetic Foot Ulcer, run by Omeza, LLC at 10 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 14 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelina Ferguson, DNP (9866294013, dr.aferguson@sygnola.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Closure (time frame: 1-12 weeks). 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 4 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.