Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
NCT ID: NCT06938685
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2025-10-06
2026-10-01
Brief Summary
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Detailed Description
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The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions. All subjects will complete a two-week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound area reduction rates, time to closure, follow-up closure, and pain assessment.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
* Standard of care
* NeoThelium FT in addition to standard of care
TREATMENT
NONE
Study Groups
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No Intervention: Standard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
Standard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
Intervention: NeoThelium FT & Standard of Care
Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading
NeoThelium FT
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Interventions
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Standard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
NeoThelium FT
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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SygNola, LLC
INDUSTRY
NuScience Medical Biologics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Desmond Bell, DPM
Role: STUDY_CHAIR
SygNola, LLC
Locations
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MedCentris of Alexandria
Alexandria, Louisiana, United States
MedCentris of Monroe
Monroe, Louisiana, United States
MedCentris of Natchez
Natchez, Mississippi, United States
MedCentris of Picayune
Picayune, Mississippi, United States
Pace Foot and Ankle Center
Bryn Mawr, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OMNEO
Identifier Type: -
Identifier Source: org_study_id
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