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

NCT05417425 | Completed Phase 1 FDA Drug

• 1 other identifier: OM-CTP-003.1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.

Conditions

Diabetic Foot Ulcers

Keywords

Chronic ulcers; Refractory wounds

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  14 weeks

Secondary Outcomes (3)

• Incidence of adverse events

  14 weeks

• Change in subject's perception of pain at baseline and weekly throughout treatment

  14 weeks

• Increase in physical function and ambulation

  14 weeks

Study Arms (1)

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.

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

Interventions

Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant COMBINATION_PRODUCT

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

Omeza combination therapy and SOC with total contact cast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (1)

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Richard Simman, MD

  ProMedica Physician Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 14, 2022
• Study Start: September 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

US (1)