Status:
RECRUITING
Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
Lead Sponsor:
NuScience Medical Biologics, LLC
Collaborating Sponsors:
SygNola, LLC
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet ...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- Index ulcer is free of necrotic debris prior to NeoThelium FT application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm
Exclusion
- 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
- 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
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
- 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
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index ulcer leg within 30 days of screening phase
- Index ulcer suspicious of neoplasm in the opinion of the principal investigator
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06938685
Start Date
October 6 2025
End Date
October 1 2026
Last Update
December 4 2025
Active Locations (5)
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1
MedCentris of Alexandria
Alexandria, Louisiana, United States, 71301
2
MedCentris of Monroe
Monroe, Louisiana, United States, 71201
3
MedCentris of Natchez
Natchez, Mississippi, United States, 39120
4
MedCentris of Picayune
Picayune, Mississippi, United States, 39466