NCT07161830 Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
| NCT ID | NCT07161830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Omeza, LLC |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-12-04 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Angelina Ferguson, DNP
STUDY DIRECTOR
SygNola, LLC
Frequently Asked Questions
Who can join the NCT07161830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07161830 currently recruiting?
Yes, NCT07161830 is actively recruiting participants. Contact the research team at dr.aferguson@sygnola.com for enrollment information.
Where is the NCT07161830 trial being conducted?
This trial is being conducted at Evergreen Park, United States, Denham Springs, United States, Leesville, United States, Marksville, United States and 6 additional locations.
Who is sponsoring the NCT07161830 clinical trial?
NCT07161830 is sponsored by Omeza, LLC. The principal investigator is Angelina Ferguson, DNP at SygNola, LLC. The trial plans to enroll 130 participants.