NeoThelium FT amnion graft for diabetic foot ulcers

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

This project will try weekly NeoThelium FT amnion skin grafts plus usual wound care to see if they help heal diabetic foot ulcers in adults with diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NuScience Medical Biologics, LLC (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Alexandria, Louisiana and 2 other locations)
• Trial ID: NCT07039396 on ClinicalTrials.gov

What this trial studies

This is a multi-center, open-label prospective case series of NeoThelium FT (dehydrated complete human placental membrane) applied weekly in addition to standard of care for diabetic foot ulcers. Eligible adults with Type 1 or Type 2 diabetes and Wagner grade 1–3 ulcers (0.5–25 cm2) with adequate circulation will receive weekly applications and follow scheduled follow-up visits. The study is post-marketing and will collect safety and healing outcomes while generating real-world evidence to support reimbursement decisions. Investigators and participants will know the treatment being given and outcomes will be tracked across participating MedCentris centers in Louisiana.

Who should consider this trial

Good fit: Adults (≥18) with Type 1 or Type 2 diabetes who have a noninfected diabetic foot ulcer of Wagner grade 1–3 measuring 0.5–25 cm2 and adequate lower-extremity circulation as documented by ABI, TBI, or arterial ultrasound are ideal candidates.

Not a fit: Patients with actively infected ulcers, clinically visible exposed bone, severe peripheral ischemia (ABI ≤0.7 or TBI ≤0.6), ulcers outside the size range, or those unable to comply with follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the graft could speed wound closure and reduce complications such as prolonged nonhealing or the need for more invasive interventions.

How similar studies have performed: Other clinical work with dehydrated placental membrane and similar cellular/acellular placental products has shown improved healing rates in diabetic foot ulcers, though product-specific and large-scale randomized evidence remains limited.

Eligibility criteria

Inclusion Criteria:

1. Male or Female, 18 years of age or older
2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy with a diabetic foot ulcer
3. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.
4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
5. Subject is able and willing to follow the protocol requirements
6. Subject had signed informed consent
7. 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.
8. Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit

Exclusion Criteria:

1. Subject is unable to comply with protocol treatment
2. Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
3. Wagner 3, 4, or 5 involving tendon, bone, or joint.
4. Presence of systemic infection, sepsis, or osteomyelitis at screening.
5. Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
6. 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.
7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
11. Subject is pregnant or breastfeeding
12. 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
13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Where this trial is running

Alexandria, Louisiana and 2 other locations

• MedCentris of Alexandria — Alexandria, Louisiana, United States (RECRUITING)
• MedCentris of Leesville — Leesville, Louisiana, United States (RECRUITING)
• MedCentris of Many — Many, Louisiana, United States (RECRUITING)

Study contacts

• Study coordinator: Angelina Ferguson, DNP

Conditions: Diabetic Foot Ulcer, Chronic Wounds, Cellular, Acellular, Matrix-like product, Cellular and/or Tissue Product, Dehydrated Complete Human Placental Membrane