Actively Recruiting
Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
Led by Omeza, LLC · Updated on 2025-12-17
130
Participants Needed
3
Research Sites
68 weeks
Total Duration
On this page
Sponsors
O
Omeza, LLC
Lead Sponsor
S
SygNola, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, 18 years of age or older
- Diagnosis of Type I or Type II Diabetes Mellitus requiring oral or insulin treatment
- Diabetic foot ulcer present for 4 weeks or more, less than 12 months if treated continuously with standard care
- Ulcer showing less than 25% healing in the 14 days before screening and before randomization
- Ulcer is Wagner grade 1, 2, or 3 without infection or visible exposed bone; Wagner 3 allowed if acute osteomyelitis treated with IV antibiotics
- Ulcer size between 0.7 cm² and 25 cm² at first treatment
- Offloading therapy used for 14 days before randomization
- Adequate circulation shown by ABI >0.7 and <1.3 or TBI >0.6 within 30 days prior or arterial ultrasound within 90 days
- Ulcer free of infection and necrotic debris before randomization and treatment
- Negative pregnancy test for females of childbearing potential
- Able and willing to follow protocol requirements
- Signed informed consent
- Multiple ulcers must be at least 2 cm apart
You will not qualify if you...
- Life expectancy less than 1 year
- Unable to comply with protocol treatment
- Major uncontrolled medical disorders affecting wound healing
- Active or history of malignancy or radiation at wound site
- Comorbid conditions compromising safety
- Contraindications to acellular matrices
- Participation in other clinical trials with interfering treatments
- Pregnant or breastfeeding
- Recent immunosuppressant, chemotherapy, or topical steroid use near ulcer
- Ulcer treated with certain advanced therapies within 30 days
- Wagner 3 ulcer with active infection not treated or chronic refractory osteomyelitis
- Wound depth with exposed bone
- Hyperbaric oxygen therapy within 14 days
- Revascularization surgery within 30 days
- Ulcer suspicious for cancer per investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
MedCentris of Denham Springs
Denham Springs, Louisiana, United States, 70726
Actively Recruiting
2
MedCentris of Leesville
Leesville, Louisiana, United States, 71446
Actively Recruiting
3
MedCentris of Southaven
Southaven, Mississippi, United States, 38671
Actively Recruiting
Research Team
A
Angelina Ferguson, DNP
CONTACT
S
Sarah Moore, MBE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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