Actively Recruiting
Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
10
Participants Needed
2
Research Sites
4 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 research aims to evaluate how well NeoThelium FT Amnion Skin Graft works and how safe it is for treating chronic pressure ulcers. The study will take place at multiple medical centers using an open-label design, meaning both patients and researchers will know which treatment is being given. It is a post-marketing study intended to gather information on the treatment's effectiveness and to support insurance reimbursement decisions. Participants will receive standard care plus weekly applications of NeoThelium FT, which is a dehydrated wound covering made from donated human placental tissue with amnion and chorion layers. Treatment includes wound cleansing, sharp debridement, applying NeoThelium FT, dressing for moisture balance, and offloading to reduce pressure. Patients will continue follow-ups according to the original schedule. During the study, participants will be assessed for wound healing progress including complete wound closure within 1 to 16 weeks, percent area reduction, wound closure at 2 weeks, and the number of grafts used. Researchers will monitor safety and treatment adherence throughout the study period, which is expected to last up to 16 weeks. This helps understand the treatment's impact on chronic pressure ulcers over time.
CONDITIONS
Brief 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 located on the pelvis or lower extremity
- Pressure Injury/Ulcer Stage 2 or 3 without infection
- Index ulcer size between 1 cm² and 30 cm² at first treatment visit
- Index ulcer depth of C 1 cm and compliant with continuous NPWT (75-100 mmHg) if applicable
- Index ulcer depth over 1 cm and compliant with continuous NPWT (75-100 mmHg)
- Use of offloading therapy while standing, sitting, and lying down for 7 days prior to first treatment
- Adequate circulation of ulcer if on lower extremity, with ABI >0.7 and <1.3 or TBI >0.6 within 30 days prior
- Index ulcer free of infection and necrotic debris prior to treatment
- Female subjects of childbearing potential must have negative pregnancy test prior to treatment
- Ability and willingness to follow protocol requirements
- Signed informed consent
- If multiple ulcers, they must be separated by at least 2 cm
You will not qualify if you...
- Known life expectancy of less than 1 year
- Inability to comply with protocol treatment
- Major uncontrolled medical disorders affecting wound healing as judged by investigator
- Active treatment for malignant disease or history of malignancy or radiation therapy at wound site
- Comorbid conditions compromising safety as judged by investigator
- Known contraindications to tissue-engineered allograft
- Participation in other clinical trials with investigational drugs or products affecting wound healing
- Pregnancy or breastfeeding
- Recent or anticipated use of immunosuppressants, cytotoxic chemotherapy, or topical steroids to ulcer
- Wound treated with CAMPs, tissue-engineered, or scaffold materials within 30 days prior
- Pressure Injury/Ulcer Stage 4 or active osteomyelitis
- Wound with visible exposed bone
- Hyperbaric oxygen therapy within 14 days prior
- Revascularization surgery on affected leg within 30 days prior
- Ulcer suspicious of neoplasm as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 to 16 weeks
Participants receive standard of care plus weekly applications of NeoThelium FT to treat their chronic pressure ulcers.
Weekly visits for up to 16 weeks
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
S
Sarah Moore, MBE
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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