NeoThelium FT with standard wound care for diabetic foot ulcers

Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial

This trial will test whether adding NeoThelium FT to standard wound care helps adults with chronic diabetic foot ulcers heal faster than standard care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NuScience Medical Biologics, LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 8 sites (Alexandria, Louisiana and 7 other locations)
• Trial ID: NCT06938685 on ClinicalTrials.gov

What this trial studies

This is an open-label, randomized controlled crossover trial conducted at multiple medical centers comparing standard of care (SOC) alone versus SOC plus NeoThelium FT. Adult participants with chronic diabetic foot ulcers who meet healing‑rate and size criteria are randomized to one of the two arms, and SOC arm subjects who have not closed by about 84 days may cross over to receive NeoThelium FT. NeoThelium FT is applied weekly for up to 12 treatment visits in the active arm, and the primary endpoint is the percentage of target ulcers achieving complete closure within 12 weeks. Secondary outcomes include wound area reduction, time to closure, follow-up closure, and pain measures, and the study is conducted as a post‑marketing effort to support reimbursement decisions.

Who should consider this trial

Good fit: Adults (18+) with type 1 or type 2 diabetes who have a chronic diabetic foot ulcer present ≥4 weeks but <12 months, showing <25% healing over 14 days, Wagner grade 1–3 without active infection or exposed bone, and an index ulcer size between 0.5 and 25 cm² are ideal candidates.

Not a fit: Patients with actively infected ulcers, clinically exposed bone that has not been treated, ulcers smaller than 0.5 cm² or larger than 25 cm², or wounds that are already healing well (>25% in 14 days) are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, adding NeoThelium FT could increase the proportion of diabetic foot ulcers that fully close within 12 weeks, potentially lowering complication and amputation risk.

How similar studies have performed: Other placental membrane and matrix-type products have shown promise in improving diabetic foot ulcer healing in prior trials, though efficacy varies by product and study.

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
3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
6. 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.
7. Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization
9. Adequate circulation of ulcer demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.
10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.
11. Index ulcer is free of necrotic debris prior to NeoThelium FT application
12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
13. Subject is able and willing to follow the protocol requirements
14. Subject had signed informed consent
15. 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 expectance 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
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 device 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 \>2 weeks duration within 30 days prior to randomization; 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 randomization
11. Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis
12. Wound depth with visible exposed bone
13. HBOT within 14 days prior to randomization
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 principal investigator

Where this trial is running

Alexandria, Louisiana and 7 other locations

• MedCentris of Alexandria — Alexandria, Louisiana, United States (Recruiting)
• MedCentris of Franklinton — Franklinton, Louisiana, United States (Recruiting)
• MedCentris of Hammond — Hammond, Louisiana, United States (Recruiting)
• MedCentris of Minden — Minden, Louisiana, United States (Recruiting)
• MedCentris of Monroe — Monroe, Louisiana, United States (Recruiting)
• MedCentris of Natchez — Natchez, Mississippi, United States (Completed)
• MedCentris of Picayune — Picayune, Mississippi, United States (Recruiting)
• Pace Foot and Ankle Center — Bryn Mawr, Pennsylvania, United States (Completed)

Study contacts

• Study coordinator: Angelina Ferguson, DNP

Conditions Diabetic Foot Ulcer; Chronic wounds; Wound Medicine; Cellular, Acellular, Matrix-like Product; Cellular and/or Tissue Product; Dehydrated Complete Human Placental Membrane