RecruitingNot Applicable

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers

United States10 participantsStarted 2025-12-01

Plain-language summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure 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 Pressure Injury/Ulcer located on the pelvis or lower extremity
✓. Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
✓. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit
✓. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
✓. Index ulcer has a depth of \> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
✓. Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit
✓. Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to the first treatment visit

✕. Subject has a known life expectancy of \<1 year
✕. Subject is unable to comply with protocol treatment
✕. 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 in the opinion of the investigator
✕. 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 to tissue-engineered allograft
✕. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
✕. Subject is pregnant or breastfeeding

Complete Wound Closure

Timeframe: 1-16 weeks

NCT IDNCT07158658

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

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 Pressure Injury/Ulcer located on the pelvis or lower extremity
✓. Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection
✓. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit
✓. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion
✓. Index ulcer has a depth of \> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg
✓. Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit
✓. Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to the first treatment visit

✕. Subject has a known life expectancy of \<1 year
✕. Subject is unable to comply with protocol treatment
✕. 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 in the opinion of the investigator
✕. 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 to tissue-engineered allograft
✕. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
✕. Subject is pregnant or breastfeeding