RecruitingNot Applicable

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

United States10 participantsStarted 2025-09-02

Plain-language summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Complete Wound Closure

Timeframe: 1-12 weeks

NCT IDNCT07061613

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Angelina Ferguson, DNP

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.