RecruitingNot Applicable

Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

United States132 participantsStarted 2025-10-06

Plain-language summary

This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or Female, 18 years of age or older
✓. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
✓. 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
✓. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
✓. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
✓. 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.
✓. Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
✓. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization

Exclusion criteria

✕. Subject has a known life expectance of \<1 year
✕. Subject is unable to comply with protocol treatment
✕. 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
✕. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
✕. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
✕. Known contraindications to tissue-engineered allograft
✕. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and/or healing
✕. Subject is pregnant or breastfeeding

What they're measuring

Complete Wound Closure

Timeframe: 1-12 weeks

Trial details

NCT IDNCT06938685

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Angelina Ferguson, DNP

(985) 629-4013 info@sygnola.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials