Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers (NCT05087758) | Clinical Trial Compass
CompletedNot Applicable
Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers
United States108 participantsStarted 2022-03-01
Plain-language summary
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications.
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Be male or female, between 21 and 80 years of age at the time of consent
âś“. For subjects with a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit
âś“. Have a full-thickness wound of the lower extremity
âś“. Have a single target ulcer
âś“. Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
âś“. Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2:
âś“. Have an absence of infection based on Infectious Disease Society of America criteria
âś“. Have an adequate circulation to the affected lower extremity, defined as at least one these criteria: