Omeza Complete Matrix to help heal diabetic foot ulcers

Evaluation of the Efficacy of Omeza® Complete Matrix in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial

This test will see if adding OCM (Omeza Complete Matrix) to standard wound care helps adults with diabetic foot ulcers heal completely.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Omeza, LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Denham Springs, Louisiana and 2 other locations)
• Trial ID: NCT07161830 on ClinicalTrials.gov

What this trial studies

This open-label, randomized study compares standard of care (SOC) alone to SOC plus OCM in adults with chronic diabetic foot ulcers. Participants who do not achieve complete closure by about day 84 and still meet criteria may cross over from SOC to receive weekly OCM applications for up to 12 treatments. Investigators will measure wound size and closure over the treatment and follow-up visits to determine the proportion of ulcers that heal completely. As a post-marketing study, it also collects real-world efficacy data to support insurance reimbursement decisions.

Who should consider this trial

Good fit: Adults (18+) with type 1 or 2 diabetes who have a nonhealing diabetic foot ulcer present ≥4 weeks (and <12 months if on continuous SOC), with <25% reduction in size over the prior 14 days, Wagner grade 1–3 without active exposed bone, and an index ulcer between 0.7 and 25 cm2 are the intended candidates.

Not a fit: Patients with active wound infection or untreated exposed bone, wounds smaller than 0.7 cm2 or larger than 25 cm2, rapidly healing ulcers, or inability to attend regular clinic visits are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding OCM to standard care could increase the rate of complete wound closure and shorten healing time for diabetic foot ulcers.

How similar studies have performed: Other biologic and extracellular matrix products have shown promise in improving diabetic foot ulcer healing, but data specific to Omeza OCM are limited and being collected in this post-marketing setting.

Eligibility criteria

Inclusion Criteria:

1. Male or Female, 18 years of age or older
2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
3. 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
4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
6. 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.
7. Index ulcer is a minimum of 0.7cm2 and a maximum of 25cm2 at first treatment visit
8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization
9. 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.
10. 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.
11. Index ulcer is free of necrotic debris prior to OCMTM application
12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
13. Subject is able and willing to follow the protocol requirements
14. Subject had signed informed consent
15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria:

1. Subject has a known life expectance of \<1 year
2. Subject is unable to comply with protocol treatment
3. 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
4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
6. Known contraindications to Acellular matrices
7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and/or healing
8. Subject is pregnant or breastfeeding
9. 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
10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
11. 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
12. Wound depth with visible exposed bone
13. HBOT within 14 days prior to randomization
14. Revascularization surgery on the index ulcer leg within 30 days of screening phase
15. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Where this trial is running

Denham Springs, Louisiana and 2 other locations

• MedCentris of Denham Springs — Denham Springs, Louisiana, United States (Recruiting)
• MedCentris of Leesville — Leesville, Louisiana, United States (Recruiting)
• MedCentris of Southaven — Southaven, Mississippi, United States (Recruiting)

Study contacts

• Study coordinator: Angelina Ferguson, DNP

Conditions Diabetic Foot Ulcer; Chronic Wounds; Wound Medicine