BridgeMD
Tests treatment safety and results for Diabetic Foot Ulcer
Official title Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT07161830
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- 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 \ 0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to...
- 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 people 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Evergreen Park, Illinois, United States
- Denham Springs, Louisiana, United States
- Leesville, Louisiana, United States
- Marksville, Louisiana, United States
- Slidell, Louisiana, United States
- Vidalia, Louisiana, United States
- Cleveland, Mississippi, United States
- Southaven, Mississippi, United States
- Newark, Ohio, United States
- Sylvania, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Evergreen Park, Illinois, United States; Denham Springs, Louisiana, United States; Leesville, Louisiana, United States; Marksville, Louisiana, United States; Slidell, Louisiana, United States; Vidalia, Louisiana, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.