CompletedNot Applicable

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Open Wounds

United States10 participantsStarted 2025-08-25

Plain-language summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Open Wounds

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 "other" Open wound
✓. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record)
✓. Ulcer area is a minimum of 1 cm2 and a maximum of 25 cm2 at first treatment visit
✓. Index wound has a maximum depth of 1cm at the first treatment visit
✓. Subject is able and willing to follow the protocol requirements
✓. Subject had signed informed consent
✓. 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.

✕. Subject is unable to comply with protocol treatment
✕. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
✕. Presence of systemic infection, sepsis, or osteomyelitis at screening.
✕. Multiple wounds at the same site of the referenced wound with \< 2 cm separation from the target ulcer.
✕. 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.
✕. 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.

Complete Wound Closure

Timeframe: 1-14 weeks

NCT IDNCT07041177

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-10

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 "other" Open wound
✓. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record)
✓. Ulcer area is a minimum of 1 cm2 and a maximum of 25 cm2 at first treatment visit
✓. Index wound has a maximum depth of 1cm at the first treatment visit
✓. Subject is able and willing to follow the protocol requirements
✓. Subject had signed informed consent
✓. 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.

✕. Subject is unable to comply with protocol treatment
✕. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
✕. Presence of systemic infection, sepsis, or osteomyelitis at screening.
✕. Multiple wounds at the same site of the referenced wound with \< 2 cm separation from the target ulcer.
✕. 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.
✕. 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.