Is NCT07116876 recruiting in Fresno, CA?

Yes, NCT07116876 is currently recruiting participants at its Fresno, CA location. This diabetic foot ulcer (dfu) clinical trial is actively enrolling qualified participants.

How do I join the diabetic foot ulcer (dfu) clinical trial in Fresno?

To join this clinical trial in Fresno, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Fresno clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetic Foot Ulcer (DFU) Clinical Trial in Fresno, CA

About This Diabetic Foot Ulcer (DFU) Study in Fresno

This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.

Sponsor: LifeNet Health

Who Can Participate

Inclusion Criteria

To be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below:

Be male or female and aged between 21 and 80 years at the time of informed consent

Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit.

Have full-thickness wound of the lower extremity, below the ankle

Have a single target ulcer

Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 with a depth less than or equal to 9 mm

Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2:

Grade 1: superficial diabetic ulcer involving the full skin thickness but not underlying tissues

Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis

Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)

Have an adequate circulation to the affected lower extremity, defined as at least one of the criteria within the previous 60 days:

Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mm Hg

Ankle-brachial index (ABI) ranging from 0.8 to 1.2

At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries

Have the ability to comply with off-loading and dressing change requirements

Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments

Have provided written authorization for use and disclosure of protected health information

Have a life expectancy of greater than 6 months

Exclusion Criteria

To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:

Be pregnant or lactating

Subjects with a target wound \<30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline/Visit 2)

Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening/Visit 1 for subjects with labs collected \<30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)

Have a serum creatinine concentration of 3.0 mg/dL or greater within 30 days prior to screening (assessed at Screening/Visit 1 for subjects with labs collected \<30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)

Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin

Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol

Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit

Need for any additional concomitant dressing material other than the ones approved for this study

Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)

Have the inability to tolerate an off-loading boot

Have a known or suspected disease of the immune system

Have an active or untreated malignancy or active, uncontrolled connective tissue disease

Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit

Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline/Visit 2)

Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit

Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening/Visit 1 if subject had labs collected \<30 days of screening; assessed at Baseline/Visit 2 if subject had labs collected at screening)

Have active Charcot disease

Have undergone treatment with a living skin equivalent within the last 4 weeks before screening

Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot

Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

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 Fresno?

Yes, this clinical trial (NCT07116876) has an active research site in Fresno, CA 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 (DFU) Treatment Options in Fresno, CA

If you're searching for diabetic foot ulcer (dfu) treatment options in Fresno, CA, this clinical trial (NCT07116876) 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 Fresno research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot ulcer (dfu) 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 (dfu) clinical trials near you to find additional studies recruiting in your area.

Diabetic Foot Ulcer (DFU) Clinical Trial in Fresno, CA

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