Omeza Complete Matrix to help heal diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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 or 2
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 fish products or cod liver oil.
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 14 days prior to randomization
11. Wound depth with visible exposed bone
12. HBOT within 14 days prior to randomization
13. Revascularization surgery on the index ulcer leg within 30 days of screening phase
14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Where it's running

• SitePath Research
  Evergreen Park, Illinois, United States Recruiting
• MedCentris of Denham Springs
  Denham Springs, Louisiana, United States Recruiting
• MedCentris of Leesville
  Leesville, Louisiana, United States Recruiting
• MedCentris of Marksville
  Marksville, Louisiana, United States Recruiting
• MedCentris of Slidell
  Slidell, Louisiana, United States Recruiting
• MedCentris of Vidalia
  Vidalia, Louisiana, United States Recruiting

Study contacts

• Study coordinator: Angelina Ferguson, DNP
• Email: dr.aferguson@sygnola.com
• Phone: 9866294013

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BIOxHEAL plus standard care for nonhealing diabetic foot ulcers

  A multicenter study tests whether applying BIOxHEAL, a placental-derived biologic, to stubborn diabetic foot ulcers helps more people heal when added to standard wound care.

  Recruiting Phase 3 Applied Biologics, LLC · Boardman, Ohio · NCT07852338

• Calcaneal Bone Marrow Cells in Foot/Ankle Surgery Patients

  This observational study tests whether routine preoperative blood tests relate to the quality and behavior of mesenchymal stem cells from calcaneal bone marrow in adults undergoing foot or ankle surgery.

  Recruiting Universidade Sao Francisco · Bragança Paulista, São Paulo · NCT07802106

• L-Carnitine as an add-on for healing diabetic foot ulcers

  This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.

  Recruiting Phase 2 Ain Shams University · Cairo, Cairo Governorate and 1 other locations · NCT07768228

• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

  This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.

  Recruiting Biointelligent Technology Systems SL · Barcelona · NCT07617961

• Pulsating electromagnetic field therapy for diabetic foot ulcers

  This trial tests whether a PEMF device called CRAD ULCER X-01 helps heal chronic diabetic foot ulcers when added to standard wound care.

  Recruiting National Defence University of Malaysia · Kuala Lumpur · NCT07465640

• Transverse tibial bone transport to help heal chronic diabetic foot ulcers

  This study tests a surgical approach called transverse tibial bone transport to see if it can help heal long‑lasting diabetic foot ulcers and prevent limb loss in adults with limited treatment options.

  Recruiting Biodynamik, Inc · Jacksonville, Florida · NCT07444593

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.