Actively Recruiting
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
Led by NuScience Medical Biologics, LLC · Updated on 2026-05-06
10
Participants Needed
2
Research Sites
47 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 Venous Leg Ulcers
CONDITIONS
Official Title
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, 18 years of age or older
- Medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
- Venous leg ulcer without infection or clinically visible exposed bone
- Wound size between 1 cm2 and 30 cm2 at first treatment visit
- Adequate circulation in the lower extremity shown by ABI >0.7 and <1.3, or TBI >0.6 within 30 days before consent, or arterial ultrasound within 90 days before treatment
- Compression therapy for venous leg ulcer for 7 days before first treatment
- Wound free of necrotic debris before NeoThelium FT application
- Female participants of childbearing potential must have a negative pregnancy test before the first treatment
- Wound free of signs of infection after debridement during screening and before first treatment
- Ability and willingness to follow study protocol
- Signed informed consent
- If two or more wounds are present, they must be at least 2 cm apart
You will not qualify if you...
- Unable to comply with study treatment
- Infection present before screening
- Multiple venous leg ulcers on the same leg less than 2 cm apart
- Comorbid conditions that may affect safety or wound healing, such as serious cardiovascular, kidney, liver, lung, autoimmune, palliative care, or inherited blood disorders
- Currently treated for cancer, history of cancer, or radiation therapy at wound site
- Known allergies or sensitivities to amniotic membrane products or NeoThelium FT components
- Participation in another clinical trial involving investigational drugs or products affecting wound healing
- Pregnant or breastfeeding
- History of immunosuppressant treatment (systemic corticosteroids over 10 mg daily), chemotherapy, or topical steroids on the ulcer for more than 2 weeks within 30 days before treatment or expected use during the study
- Wound treated with cellular or tissue-engineered products within 30 days before enrollment
- Wound suspected to be cancerous by the 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 Metairie
Metairie, Louisiana, United States, 70001
Completed
2
MedCentris of Slidell
Slidell, Louisiana, United States, 70458
Actively Recruiting
Research Team
A
Angelina Ferguson, DNP
CONTACT
S
Sarah Moore
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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