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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers
Advanced wound care with debridement and dressings
Compass Medical Research Center, LLC
Tucson, Arizona, United States
Center for Clinical Research, INC
Carmichael, California, United States
Limb Preservation Platform, INC
Fresno, California, United States
ILD Research Center
San Diego, California, United States
Center for Clinical Research, INC
San Francisco, California, United States
Doctors Research Network
Miami, Florida, United States
Albuquerque Associated Podiatrists
Albuquerque, New Mexico, United States
Purvis-Moyer Foot and Ankle Center
Rocky Mount, North Carolina, United States
Wound Healing
Proportion of chronic DFUs that have achieved complete wound closure
Time frame: 12 weeks
Speed of Wound Closure
Time to wound closure measured from the baseline visit to the termination visit
Time frame: 12 weeks
Wound Area
Change in wound area over time
Time frame: 12 weeks
Infection
Rate of wound infection
Time frame: 12 weeks
Reoccurrence
Rate of reoccurrence of wound post treatment
Time frame: 6 months post termination visit
Grafts Used
Average number of Matrion grafts used per subject
Time frame: 12 weeks
Incidence of Treatment Emergent Adverse Events
Collection of adverse events, including changes in vital signs, ABI, and physical exams
Time frame: 12 weeks
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