Status:
NOT_YET_RECRUITING
Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries
Lead Sponsor:
NuScience Medical Biologics, LLC
Collaborating Sponsors:
SygNola, LLC
Conditions:
Pressure Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet ...
Eligibility Criteria
Inclusion
- 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 Pressure Injury/Ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
- Subject has a Pressure Injury/Ulcer Stage 2, 3, and 4 without infection or clinically visible exposed bone
- Index ulcer is a minimum of 1cm2 and a maximum of 25cm2 at first treatment visit
- Index ulcer has a maximum depth of 1cm at first screening visit
- Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 14 days prior to randomization
- Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization
- Index ulcer is free of infection prior to randomization and during screening phase.
- Index ulcer is free of necrotic debris prior to \[insert product/device\] application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
- Having a Mini Nutritional Assessment Score of 12 or higher indicated a normal nutritional status
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm
Exclusion
- 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
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
- Known contraindications to tissue-engineered allograft
- Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
- Wound reduces in area by ≥25% after 14 days of SOC prior to randomization
- Subject is pregnant or breastfeeding
- Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
- Pressure Injury/Ulcer of Stage 4 grade with active osteomyelitis or exposed visible bone
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06918548
Start Date
March 1 2026
End Date
May 1 2028
Last Update
January 6 2026
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