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

Launched by NUSCIENCE MEDICAL BIOLOGICS, LLC · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NeoThelium FT, which is a special skin graft made from human placental tissue, to help heal diabetic foot ulcers. These ulcers are wounds that can develop on the feet of people with diabetes and can be hard to heal. The study aims to see if this treatment is both safe and effective in helping these wounds get better.

People who may be eligible to join are adults with type 1 or type 2 diabetes who have a diabetic foot ulcer of a certain size and severity, but without active infection or exposed bone. Participants need to have good blood flow to their feet and be able to follow the study’s instructions. Before starting, the wound should be free of infection and treated with standard care like special offloading boots to reduce pressure on the foot. If you join, you can expect to receive the NeoThelium FT graft applied to your wound and be monitored over time to see how well your ulcer heals and to ensure the treatment is safe. This study is not yet recruiting, but it could offer a promising option for people struggling with diabetic foot ulcers.

Gender

ALL

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