NeoThelium FT amnion skin graft to help heal venous leg ulcers.

Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series

The team will try weekly NeoThelium FT amnion skin graft applications together with standard compression therapy to see if they help heal venous leg ulcers in adults.

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 (Metairie, Louisiana and 1 other locations)
• Trial ID: NCT07061613 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label case series conducted at multiple outpatient centers where all participants and clinicians know the treatment being given. Eligible adults with venous leg ulcers (1–30 cm2) who have adequate circulation and are on compression therapy will receive standard of care plus weekly NeoThelium FT applications and follow routine clinic visits. The study will collect wound healing and safety data over the follow-up period and is conducted as a post-marketing effort that may support insurance reimbursement decisions. Investigators will document wound size, signs of infection, and any adverse events while monitoring for complete or partial healing.

Who should consider this trial

Good fit: Adults 18 or older with a diagnosed venous leg ulcer (1–30 cm2), adequate lower-extremity arterial circulation, no clinical infection or exposed bone, and who have been on compression therapy will be the ideal candidates.

Not a fit: Patients with significant arterial insufficiency, clinically infected or necrotic wounds, wounds outside the 1–30 cm2 range, or other contraindications to placental-derived grafts are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, NeoThelium FT could speed healing of venous leg ulcers and reduce time with open wounds compared with standard care alone.

How similar studies have performed: Other studies of placental and amniotic membrane products have reported promising healing results in chronic wounds, though evidence is mixed and higher-quality trials remain limited.

Eligibility criteria

Inclusion Criteria:

1. Male or Female, 18 years of age or older
2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
3. Subject has an venous leg ulcer without infection or clinically visible exposed bone
4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
5. 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.
6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
7. Index wound is free of necrotic debris prior to NeoThelium FT application
8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
9. Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
10. Subject is able and willing to follow the protocol requirements
11. Subject had signed informed consent
12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm

Exclusion Criteria:

1. Subject is unable to comply with protocol treatment
2. Presence of infection prior to screening.
3. Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
4. 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
5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
7. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
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 the first treatment visit; 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 enrollment
12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Where this trial is running

Metairie, Louisiana and 1 other locations

• MedCentris of Metairie — Metairie, Louisiana, United States (Completed)
• MedCentris of Slidell — Slidell, Louisiana, United States (Recruiting)

Study contacts

• Study coordinator: Angelina Ferguson, DNP

Conditions Venous Leg Ulcer; Chronic Wounds; Cellular, Acellular, Matrix-like Product; Cellular and/or Tissue Product; Dehydrated Complete Human Placental Membrane