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
Parallel
Standard of Care
Other interventionWound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
NeoThelium FT
Other interventionNeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
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 digital photographic planimetry and physical examination.
Time to Closure
Average number of grafts and/or weeks used to achieve wound closure
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Pain Assessment
Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points
Wound closure rate in comparison to initial area
Wound healing rate vs wound area categories 0.5-1 cm2, \>1-3cm2, \>3-5cm2, etc.
Adverse Events and Serious Adverse Events
The number and nature of adverse events (AEs) and series adverse events (SAEs) occurring during the study will be tracked and reported.
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NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
