Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorLifeNet Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Graft Application
- Wound Dressing Material
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov