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Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

NeoThelium FT with standard wound care for diabetic foot ulcers

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

Run by NuScience Medical Biologics, LLC · NCT06938685 · Data updated 2026-11-12

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.

More Diabetic Foot Ulcer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment132 (estimated)
SponsorNuScience Medical Biologics, LLC
Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations8 sites (Alexandria, Louisiana and 7 other locations)
StatusRecruiting
StartedOctober 6, 2025
Main results expectedSeptember 1, 2026
Study endsOctober 1, 2026
Registry record updatedJune 17, 2026
Trial IDNCT06938685 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • MedCentris of Alexandria
    Alexandria, Louisiana, United States     Recruiting
  • MedCentris of Hammond
    Hammond, Louisiana, United States     Recruiting
  • MedCentris of Minden
    Minden, Louisiana, United States     Recruiting
  • MedCentris of Picayune
    Picayune, Mississippi, United States     Recruiting
  • MedCentris of Franklinton
    Franklinton, Louisiana, United States     Completed
  • MedCentris of Monroe
    Monroe, Louisiana, United States     Completed
Show 2 more locations
  • MedCentris of Natchez
    Natchez, Mississippi, United States     Completed
  • Pace Foot and Ankle Center
    Bryn Mawr, Pennsylvania, United States     Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Diabetic Foot Ulcer 66NuScience Medical Biologics, LLC 4
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.