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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.
The wound will be debrided and undergo a moist-wound therapy and will be covered with a gauze that is appropriate for the type of wound (moist or dry). Dressings will cover each wound wound for at least 5 days, but no more than 9 days, (7 days +/- 2 days) until the next study visit. Off-loading of the wound is required.
Compass Medical Research Center
Tucson, Arizona, United States
Bay Area Foot Care
Castro Valley, California, United States
Limb Preservaion Platform, Inc.
Fresno, California, United States
Center for Clinical Research, Inc
San Francisco, California, United States
Bay Area Foot Care
San Francisco, California, United States
ILD Research Center
Vista, California, United States
Humanity Clinical Research, Corp
Aventura, Florida, United States
Dinamo Research & Diagnostic Center, LLC
Hialeah, Florida, United States
Doctors Research Network, Inc.
Miami, Florida, United States
Independent Clinical Research
Decatur, Illinois, United States
...and 7 more locations
Wound Healing
Proportion of diabetic foot ulcers 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
Change in Wound Area
Change in wound area over time
Time frame: 12 weeks
Assessment of Wound Closure Rates in Study Participants
Number of subjects with a healed wound
Time frame: 12 weeks
Infection
Rate of wound infection
Time frame: 12 weeks
Reoccurrence
Rate of re-occurrence of wound during follow-up period
Time frame: 14 weeks
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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