Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers

NCT07161830 | Recruiting FDA Device

• 1 other identifier: Ocdiam
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetic Foot Ulcer

Keywords

Chronic Wounds; Wound Medicine

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks.

  1-12 weeks

Secondary Outcomes (2)

• Percentage Wound Area Change

  1-12 weeks

• Pain Assessment

  1-12 weeks

Other Outcomes (4)

• Hemoglobin A1c

  1-16 weeks

• Time to Closure

  1-12 weeks

• Follow-Up Closure

  2-weeks

Study Arms (2)

OCM + SOC

EXPERIMENTAL

Omeza® Complete Matrix (OCM™) is a wound care matrix comprised of hydrolyzed fish collagen derived from whitefish skin

Device: Omeza® Complete Matrix

Standard of Care

ACTIVE COMPARATOR

Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Other: Standard of Care

Interventions

Standard of Care OTHER

Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Also known as: SOC

Standard of Care

Omeza® Complete Matrix DEVICE

OCM Application, Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Also known as: OCM

OCM + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 less than 12 months duration if 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, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
• 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

You may not qualify if:

• 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 Acellular matrices
• 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 30 days prior to randomization
• Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis
• 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

Sponsors & Collaborators

• Omeza, LLC: lead
• SygNola, LLC: collaborator

Study Sites (3)

MedCentris of Denham Springs

Denham Springs, Louisiana, 70726, United States

RECRUITING

MedCentris of Leesville

Leesville, Louisiana, 71446, United States

RECRUITING

MedCentris of Southaven

Southaven, Mississippi, 38671, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Angelina Ferguson, DNP

  SygNola, LLC

  STUDY DIRECTOR

Central Study Contacts

Angelina Ferguson, DNP

CONTACT

9866294013; dr.aferguson@sygnola.com

Sarah Moore, MBE

CONTACT

986-629-4013; sarah.moore@sygnola.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The subject will be randomized to one of the following treatments: * Standard of care * OCM in addition to standard of care

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 9, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (3)