Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers

Launched by NUSCIENCE MEDICAL BIOLOGICS, LLC · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called NeoThelium FT to see how effective it is for healing venous leg ulcers when used alongside standard care. Venous leg ulcers are open wounds on the legs caused by poor blood flow, and they can be quite challenging to heal. The trial will compare how well patients do with NeoThelium FT and standard care versus those who only receive standard care. The study is not yet recruiting participants, but it aims to involve adults aged 18 and older who have had a venous leg ulcer for at least four weeks and less than 12 months, among other criteria.

To be eligible for the trial, participants must have a diagnosis of venous insufficiency with an open wound, and their ulcer must show limited healing before joining the study. They should not have any infections in their ulcer, must be able to follow the treatment plan, and need to provide their consent to participate. If you or someone you know is dealing with a venous leg ulcer and meets these criteria, this trial could offer a potential new treatment option. Participants will receive detailed information about the study and what to expect, ensuring they feel supported throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or Female, 18 years of age or older
• • 2. Subject has a medical diagnosis of Venous Insufficiency with an open wound to the lower extremity
• • 3. Subject has a Venous Leg Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
• • 4. Subject has a Venous Leg Ulcer with a historical wound measurement showing less than 50% healing in 30 days prior to randomization
• • 5. Subject has a Venous Leg Ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
• • 6. Subject has a Venous Leg Ulcer Wagner 1, 2, and 3 without infection or clinically visible exposed bone
• • 7. Index ulcer is a minimum of 1cm2 and a maximum of 40cm2 at first treatment visit
• • 8. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to randomization
• • 9. Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization
• • 10. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
• • 11. Index ulcer is free of necrotic debris prior to NeoThelium FT application
• • 12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
• • 13. Subject is able and willing to follow the protocol requirements
• • 14. Subject had signed informed consent
• • 15. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm
• Exclusion Criteria:
• • 1. Subject has a known life expectancy of \<1 year
• • 2. Subject is unable to comply with protocol treatment
• • 3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
• • 4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
• • 5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
• • 6. Known contraindications to tissue-engineered allograft
• • 7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
• • 8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization
• • 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 randomization; 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 randomization
• • 12. Venous Leg Ulcer with active infection
• • 13. Wound depth with visible exposed bone
• • 14. HBOT within 14 days prior to randomization
• • 15. Revascularization surgery on the index ulcer leg within 30 days of screening phase
• • 16. Index ulcer suspicious of neoplasm in the opinion of the principal investigator