NeoThelium FT treatment for chronic pressure ulcers
Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series
This project will try NeoThelium FT amnion skin graft plus usual wound care in adults with stage 2–3 chronic pressure ulcers to see if it helps wounds heal and is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NuScience Medical Biologics, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Bossier City, Louisiana and 1 other locations) |
| Trial ID | NCT07158658 on ClinicalTrials.gov |
What this trial studies
This is an open‑label, prospective case series conducted at multiple centers where all participants receive weekly NeoThelium FT applications in addition to standard of care. Eligible adults have stage 2–3 pressure ulcers on the pelvis or lower extremity measuring between 1 and 30 cm2, are free of infection, and meet vascular perfusion criteria; use of offloading and negative pressure wound therapy is required when indicated. Investigators will follow enrolled patients on the scheduled visits to record wound healing outcomes and safety events. As a post‑marketing study, collected data will also support insurance reimbursement decisions.
Who should consider this trial
Good fit: Adults (≥18) with stage 2 or 3 pressure ulcers on the pelvis or lower extremity measuring 1–30 cm2, free of infection, with adequate arterial perfusion (ABI 0.7–1.3 or TBI >0.6), and willing to use offloading and prescribed NPWT when required.
Not a fit: Patients with infected ulcers, stage 4 wounds or ulcers outside the pelvis/lower extremities, poor arterial circulation outside the ABI/TBI criteria, or who cannot comply with offloading/NPWT are unlikely to benefit.
Why it matters
Potential benefit: If successful, NeoThelium FT could speed closure of chronic pressure ulcers and reduce the need for more invasive treatments.
How similar studies have performed: Other clinical reports of dehydrated human placental membrane and similar cellular/tissue products have shown promising wound‑healing results, but high‑quality comparative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity 3. Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection 4. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit 5. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion 6. Index ulcer has a depth of \> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg 7. 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 8. 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 9. Index ulcer is free of infection prior to the first treatment visit and during screening phase. 10. Index ulcer is free of necrotic debris prior to NeoThelium FT application 11. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit 12. Subject is able and willing to follow the protocol requirements 13. Subject had signed informed consent 14. If 2 or more ulcers are present, the ulcers must be separated by at least 2 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 in the opinion of the investigator 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. Subject is pregnant or breastfeeding 9. Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \>14 days duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study 10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to the first treatment visit 11. Pressure Injury/Ulcer of Stage 4 or active osteomyelitis 12. Wound depth with visible exposed bone 13. HBOT within 14 days prior to the first treatment visit 14. Revascularization surgery on the index ulcer leg within 30 days of screening phase 15. Index ulcer suspicious of neoplasm in the opinion of the investigator
Where this trial is running
Bossier City, Louisiana and 1 other locations
- MedCentris of Bossier City — Bossier City, Louisiana, United States (Recruiting)
- MedCentris of Rayville — Rayville, Louisiana, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Angelina Ferguson, DNP
- Email: dr.aferguson@sygnola.com
- Phone: 986-629-4013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.