RecruitingDiabetic Foot Ulcer
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: NuScience Medical Biologics, LLC
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Louisiana
Alexandria · Franklinton · Hammond · Minden …
Mississippi
Natchez · Picayune
Pennsylvania
Bryn Mawr
Source: ClinicalTrials.gov · NCT06938685 · last updated 2026-06-17