Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers

• ClinicalTrials.gov Identifier: NCT05417425
• Recruitment Status: Not yet recruiting
• First Posted: June 14, 2022
• Last Update Posted: September 30, 2022
• Sponsor: Omeza, LLC
• Information provided by (Responsible Party): Omeza, LLC

Tracking Information

• First Submitted Date: June 6, 2022
• First Posted Date: June 14, 2022
• Last Update Posted Date: September 30, 2022
• Estimated Study Start Date: September 2022
• Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 9, 2022)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 9, 2022)

• Incidence of adverse events [ Time Frame: 14 weeks ]
  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.
• Change in subject's perception of pain at baseline and weekly throughout treatment [ Time Frame: 14 weeks ]
  Subjects will be required to assess ulcer pain at baseline and at each treatment visit by a questionnaire assessing pain on a numerical scale
• Increase in physical function and ambulation [ Time Frame: 14 weeks ]
  Subjects will be asked to complete a questionnaire to assess physical function and ambulation status at baseline and at each treatment visit.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
• Official Title: A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
• Brief Summary: This study is to evaluate the efficacy of Omeza® Lidocaine Lavage, Omeza® Collagen Matrix and Omeza® Skin Protectant used in combination with off-loading devices for the treatment of diabetic foot ulcers.
• Detailed Description: The study will have three phases: screening, treatment and healing confirmation. The screening phase is to determine eligibility of subjects and chronicity of the diabetic foot ulcer and will include off-loading. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects will be treated weekly with the Omeza combination therapy and standard of care to continue offloading. At the conclusion of the 4 weekly treatments, healing will be assessed and continued therapy will be at the PI's discretion.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open-label, single arm to evaluate efficacy in chronic, non-healing wounds.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Diabetic Foot Ulcer

Intervention

Combination Product: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant

The three omeza products were designed to be used in combination for the treatment of chronic wounds

Study Arms

Experimental: Omeza combination therapy and SOC with total contact cast

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.

Intervention: Combination Product: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 9, 2022): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05417425
• Other Study ID Numbers: OM-CTP-003.1
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Omeza, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Omeza, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Omeza, LLC
• Verification Date: September 2022