Actively Recruiting
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
10
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
Sponsors
N
NuScience Medical Biologics, LLC
Lead Sponsor
S
SygNola, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers
CONDITIONS
Official Title
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, 18 years of age or older
- Medical diagnosis of pressure injury/ulcer on pelvis or lower extremity
- Pressure injury/ulcer at Stage 2 or 3 without infection
- Ulcer size between 1 cm² and 30 cm² at first treatment visit
- Ulcer depth ≤ 1 cm with compliance to continuous NPWT at 75-100 mmHg (provider discretion)
- Ulcer depth > 1 cm with compliance to continuous NPWT at 75-100 mmHg
- Use of offloading therapy while standing, sitting, and lying down for 7 days prior to first treatment
- Adequate circulation if ulcer is on lower extremity (ABI >0.7 and <1.3, or TBI >0.6 within 30 days prior)
- Ulcer free of infection before first treatment and during screening
- Ulcer free of necrotic debris before NeoThelium FT application
- Female participants of childbearing potential must have a negative pregnancy test before first treatment
- Ability and willingness to follow protocol requirements
- Signed informed consent
- If multiple ulcers, they must be at least 2 cm apart
You will not qualify if you...
- Known life expectancy less than 1 year
- Unable to comply with protocol treatment
- Major uncontrolled medical disorders affecting wound healing
- Active treatment for malignant disease or history of malignancy/radiation at wound site
- Comorbid conditions compromising safety
- Known contraindications to tissue-engineered allograft
- Participation in other clinical trials involving investigational drugs/products affecting wound healing
- Pregnant or breastfeeding
- History of immunosuppressant treatment or chemotherapy/topical steroids to ulcer within 30 days prior or anticipated use during study
- Wound treated with CAMPs, tissue engineered or scaffold materials within 30 days prior
- Pressure ulcer at Stage 4 or active osteomyelitis
- Wound depth with exposed bone
- Hyperbaric oxygen therapy within 14 days prior
- Revascularization surgery on ulcer leg within 30 days
- Ulcer suspicious of neoplasm as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
MedCentris of Bossier City
Bossier City, Louisiana, United States, 71111
Actively Recruiting
2
MedCentris of Rayville
Rayville, Louisiana, United States, 71269
Not Yet Recruiting
Research Team
A
Angelina Ferguson, DNP
CONTACT
S
Sarah Moore, MBE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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