RecruitingNot ApplicableNCT06938685

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

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

Sponsor

NuScience Medical Biologics, LLC

Enrollment

132 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

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 Criteria15

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

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Interventions

OTHERStandard of Care

Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading

OTHERNeoThelium 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.