NCT07061613 · NuScience Medical Biologics, LLC
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
What this study is about
This is a forward-looking case series evaluating the effectiveness and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
View original scientific description
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
- Subject has an venous leg ulcer without infection or clinically visible exposed bone
- Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
- Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
- Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
- Index wound is free of necrotic debris prior to NeoThelium FT application
- Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
- Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more wounds are present, the wounds must be separated by at least 2 cm
Exclusion criteria
- Subject is unable to comply with protocol treatment
- Presence of infection prior to screening.
- Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
- Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
- 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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
- Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
- 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 the first treatment visit; 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 enrollment
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Where
- Metairie, Louisiana
- Slidell, Louisiana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations