Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

10 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

Study team and timeline

Lead sponsor

NuScience Medical Biologics, LLC

Study start

Aug 26, 2025 Actual

Primary completion

May 22, 2026 Actual

Study completion

May 22, 2026 Actual

First posted

Jun 26, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.