Diabetic Foot UlcersPhase 1NCT05417425
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
A Phase 1 study testing Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant in people with Diabetic Foot Ulcers, run by Omeza, LLC at 1 site in United States.
Trial summary
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years old and female subjects are not pregnant
- Subject is diagnosed as having Type 1 or Type 2 diabetes
- Presence of a DFU, Wagner 1 or 2, extending at least through the dermis, provided it is below the level of the medial or lateral malleolus
- Target wound will be located on the foot or ankle and will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2cm distant from the target wound.
- 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 1.0 cm2 and a maximum of 100.0 cm2
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- Study ulcer may have characteristics that include yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue, but not mandatory
- Subject understands and is willing to participate in the clinical study including offloading prior to study start, participate in the informed consent process, and can comply with weekly visits and the follow-up regimen
- Willing and able to comply with study procedures, including study visits and study dressing regimens
- Subject has read and signed the IRB-approved Informed Consent Form before screening procedures are undertaken
Who cannot join
- Study ulcer deemed by the Investigator to be caused by a medical condition other than Diabetes
- 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 is less than 2.0 cm2 or greater than 100.0cm2
- 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
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- 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
- 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
- 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. 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) and 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, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia
- Untreated osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to treatment. (In the event of an ambiguous diagnosis, the subject will not be enrolled)
- Hepatitis
- Acute deep venous thrombosis
- Allergy to lidocaine and/or epinephrine
- Subject's inability to safely ambulate with the use of the study-required off-loading method
- Subject has unstable Charcot foot or Charcot with bone exposed that could inhibit wound healing
- 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: Heat lamps, UV lights, Whirlpool baths, Hyperbaric oxygen, Jet water streams (other than gentle saline irrigation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
Read the detailed description
The study will include three phases: screening phase, treatment phase and healing confirmation. All measurements in the trial are captured by Tissue Analytics.The two week screening phase is to confirm the chronicity of the diabetic foot ulcer (DFU) and the eligibility of subjects. Subjects will be treated with standard of care (SOC) which includes cleaning of the wound, debridement when needed, dressing, and offloading. If the ulcer decreases by 30% in area measurement after 2 weeks of SOC, then the subject does not qualify for the treatment phase. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects are treated weekly with the OCM™ therapy plus continued offloading. At the conclusion of 4 weekly treatments, the ulcer will be assessed by PI for response and evaluation of percent area reduction. Continued therapy through treatment visit 12 is at the PI's discretion where percent area reduction is assessed and recorded.
OCM™ results will be compared to a Control Group of subjects identified and matched retrospectively from the same site, who received the same advanced treatments that the OCM™ treated cohort had received prior to the trial.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
- Keywords
- Chronic ulcers, Refractory wounds
- Medical subject headings
- Diabetic Foot, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectantCombination product
The three omeza products were designed to be used in combination for the treatment of chronic wounds
| Study group | Role | What they receive |
|---|---|---|
| Omeza combination therapy and SOC with total contact cast | Experimental | Omeza's products were developed to utilize the benefits of essential omega fatty acids to reduce chronic inflammation and disrupt biofilm colonization commonly found in chronic wounds. The Omeza combination treatment under investigation in this study includes two over the counter (OTC) drugs, Omeza® Lidocaine Lavage and Omeza® Skin Protectant, and a 510(K) medical device, Omeza® Collagen Matrix.
In combination with standard of care and total contact cast, the products will be applied on a weekly basis. There will be a 14-day screening period to assess chronicity from standard of care alone. At that time treatment will be applied weekly for 4 weeks. Further treatment will be at the discretion of the PI to continue for 8 more weeks or until wound closure. Receives: Combination Product: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent area change after 4 weeks of treatment compared to baseline
After a 2 week screening phase with standard of care and total contact casting, the wound will be measured and assessed by Tissue Analytics platform. At each treatment visit the change in the wound size and healing status will be assessed. After 4 weeks of treatment the change in wound size will be compared to baseline measurement from treatment visit 1 and the percent area reduction (PAR) recorded.
Measured: 6 weeks
Incidence in wound closure by week 12 of treatment
Treatment will continue and measurements recorded by Tissue Analytics platform until wound closure or up to 12 weeks of treatment.
Measured: 14 weeks
Secondary outcomes (3)
Incidence of adverse events
Safety of the products used in combination will be assessed by the PI and assesses throughout treatment for adverse events or reactions to the products.
Measured: 14 weeks
Change in subject's perception of pain at baseline and weekly throughout treatment
Subjects will be required to assess ulcer pain at baseline and at each treatment visit by a questionnaire assessing pain on a numerical scale
Measured: 14 weeks
Increase in physical function and ambulation
Subjects will be asked to complete a questionnaire to assess physical function and ambulation status at baseline and at each treatment visit.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Sep 2022
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single arm to evaluate efficacy of 11 weekly treatments with OCM® in patients with chronic, non-healing Diabetic Foot Ulcers. Percent area reduction (PAR) measurements to be taken at week 5 treatment visit and at week 12 end of study (EOS) visit.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Simman, MD, Principal investigator, ProMedica Physician Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417425
- Sponsor's protocol ID
- OM-CTP-003.1
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05417425
- Acronym / sponsor ID
- OM-CTP-003.1
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Chronic ulcers, Refractory wounds
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jun 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.
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
Detailed description
The study will include three phases: screening phase, treatment phase and healing confirmation. All measurements in the trial are captured by Tissue Analytics.The two week screening phase is to confirm the chronicity of the diabetic foot ulcer (DFU) and the eligibility of subjects. Subjects will be treated with standard of care (SOC) which includes cleaning of the wound, debridement when needed, dressing, and offloading. If the ulcer decreases by 30% in area measurement after 2 weeks of SOC, then the subject does not qualify for the treatment phase. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects are treated weekly with the OCM™ therapy plus continued offloading. At the conclusion of 4 weekly treatments, the ulcer will be assessed by PI for response and evaluation of percent area reduction. Continued therapy through treatment visit 12 is at the PI's discretion where percent area reduction is assessed and recorded.
OCM™ results will be compared to a Control Group of subjects identified and matched retrospectively from the same site, who received the same advanced treatments that the OCM™ treated cohort had received prior to the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single arm to evaluate efficacy of 11 weekly treatments with OCM® in patients with chronic, non-healing Diabetic Foot Ulcers. Percent area reduction (PAR) measurements to be taken at week 5 treatment visit and at week 12 end of study (EOS) visit.
| Arm | Type | Receives |
|---|---|---|
| Omeza combination therapy and SOC with total contact cast | Experimental | Combination Product: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectantOmeza's products were developed to utilize the benefits of essential omega fatty acids to reduce chronic inflammation and disrupt biofilm colonization commonly found in chronic wounds. The Omeza combination treatment under investigation in this study includes two over the counter (OTC) drugs, Omeza® Lidocaine Lavage and Omeza® Skin Protectant, and a 510(K) medical device, Omeza® Collagen Matrix. In combination with standard of care and total contact cast, the products will be applied on a weekly basis. There will be a 14-day screening period to assess chronicity from standard of care alone. At that time treatment will be applied weekly for 4 weeks. Further treatment will be at the discretion of the PI to continue for 8 more weeks or until wound closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is at least 18 years old and female subjects are not pregnant
- Subject is diagnosed as having Type 1 or Type 2 diabetes
- Presence of a DFU, Wagner 1 or 2, extending at least through the dermis, provided it is below the level of the medial or lateral malleolus
- Target wound will be located on the foot or ankle and will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2cm distant from the target wound.
- 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
Key exclusion criteria (26 listed)
- Study ulcer deemed by the Investigator to be caused by a medical condition other than Diabetes
- 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 is less than 2.0 cm2 or greater than 100.0cm2
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 collagen matrix, Omeza lidocaine lavage, Omeza skin protectantThe three omeza products were designed to be used in combination for the treatment of chronic wounds | Combination product | Omeza combination therapy and SOC with total contact cast |
Primary outcome
Percent area change after 4 weeks of treatment compared to baseline
Time frame: 6 weeks
After a 2 week screening phase with standard of care and total contact casting, the wound will be measured and assessed by Tissue Analytics platform. At each treatment visit the change in the wound size and healing status will be assessed. After 4 weeks of treatment the change in wound size will be compared to baseline measurement from treatment visit 1 and the percent area reduction (PAR) recorded.
Incidence in wound closure by week 12 of treatment
Time frame: 14 weeks
Treatment will continue and measurements recorded by Tissue Analytics platform until wound closure or up to 12 weeks of treatment.
3 secondary outcomes
Incidence of adverse events
Time frame: 14 weeks
Change in subject's perception of pain at baseline and weekly throughout treatment
Time frame: 14 weeks
Increase in physical function and ambulation
Time frame: 14 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 21 Jun 2024.
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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.
Richard Simman, MD principal investigator
ProMedica Physician Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant in people with Diabetic Foot Ulcers, run by Omeza, LLC at 1 site 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 10 inclusion and 26 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 21 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 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent area change after 4 weeks of treatment compared to baseline (time frame: 6 weeks). The study lists 2 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 21 Jun 2024.