This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.
Male or Female, 18 years of age or older
Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity
Subject has a Pressure Injury/Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
Subject has a Pressure Injury/Ulcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization
Subject has a known life expectancy of <1 year
Subject is unable to comply with protocol treatment
Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator