Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers

Launched by NUSCIENCE MEDICAL BIOLOGICS, LLC · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NeoThelium FT, which is a special skin graft made from amniotic tissue, to see if it can help heal venous leg ulcers—these are wounds that happen on the lower legs due to poor blood flow in the veins. The trial will look at how well this treatment works and how safe it is for patients.

Adults aged 18 and older who have a venous leg ulcer without infection or exposed bone may be eligible to join. To qualify, the wound needs to be between 1 and 30 square centimeters in size, and blood flow to the leg must be adequate, which doctors will check before starting. Participants should also have been using compression therapy (a common treatment to improve blood flow) for at least a week before the trial. During the study, patients will receive the NeoThelium FT skin graft applied to their wound and be monitored to see how well it heals. People with infections, certain other health problems, or allergies to the treatment won’t be eligible. If you or a loved one has a venous leg ulcer and want to learn about this new option, this trial might be a possibility to consider once it begins recruiting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or Female, 18 years of age or older
• • 2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
• • 3. Subject has an venous leg ulcer without infection or clinically visible exposed bone
• • 4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
• • 5. 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.
• • 6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
• • 7. Index wound is free of necrotic debris prior to NeoThelium FT application
• • 8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
• • 9. Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
• • 10. Subject is able and willing to follow the protocol requirements
• • 11. Subject had signed informed consent
• • 12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm
• Exclusion Criteria:
• • 1. Subject is unable to comply with protocol treatment
• • 2. Presence of infection prior to screening.
• • 3. Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
• • 4. 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
• • 5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
• • 6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
• • 7. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
• • 8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
• • 9. Subject is pregnant or breastfeeding
• • 10. 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
• • 11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
• • 12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator