Newark, OHNCT07161830Now EnrollingIRB Ready

Diabetic Foot Ulcer Clinical Trial in Newark, OH

Access cutting-edge diabetic foot ulcer treatment through this clinical trial at a research site in Newark. Study-provided care at no cost to qualified participants.

Sponsored by Omeza, LLC

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Expert Care in Newark

Access diabetic foot ulcer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related diabetic foot ulcer treatment provided free

Apply for This Newark Location

Check if you qualify for this diabetic foot ulcer clinical trial in Newark, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Newark

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Newark site if eligible
  4. 4Begin participation

About This Diabetic Foot Ulcer Study in Newark

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.

Sponsor: Omeza, LLC

Who Can Participate

Inclusion 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 completed IV antibiotic treatment prior to screening.
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 \<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.
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 subjects 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

Exclusion Criteria

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 wound healing
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 to randomization; or anticipated use of the above during the course of the study
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Newark?

Yes, this clinical trial (NCT07161830) has an active research site in Newark, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetic Foot Ulcer Treatment Options in Newark, OH

If you're searching for diabetic foot ulcer treatment options in Newark, OH, this clinical trial (NCT07161830) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Newark research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot ulcer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetic foot ulcer clinical trials near you to find additional studies recruiting in your area.

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