The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States.
Study Type
OBSERVATIONAL
Enrollment
37
weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy
The Serena Group
Cambridge, Massachusetts, United States
Wound Area
Assessment of ulcer area (percent area reduction from baseline)
Time frame: 12 Weeks
Time to complete wound closure
Time to complete wound closure as defined by FDA.
Time frame: 12 Weeks
Rate of wound closure
Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction.
Time frame: 12 Weeks
Adverse Events
Incidence of adverse events
Time frame: 12 Weeks
Reduction in pain
Assessment of the pain level linked to the wound, using the validated PEG pain scale (0-10), with a higher score indicating more severe pain and pain-related interference with life and activities.
Time frame: 12 Weeks
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