This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
Male or Female, 18 years of age or older
Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
Subject has an venous leg ulcer without infection or clinically visible exposed bone
Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
Subject is unable to comply with protocol treatment
Presence of infection prior to screening.
Multiple VLUs on the same leg with < 2 cm separation from the target ulcer.
Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
Single group
NeoThelium FT (HCT/P 361)
Other interventionNeoThelium FT is a dehydrated wound covering derived from donated human placental tissue.
Complete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
Percentage Wound Area Change
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using manual measurement utilizing a ruler and physical examination.
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Time to Closure
Average number of grafts and/or weeks used to achieve wound closure
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NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator
