RecruitingNot ApplicableNCT07039396

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series

Sponsor

NuScience Medical Biologics, LLC

Enrollment

10 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

Summary

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 with a diabetic foot ulcer
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.
Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
Subject is able and willing to follow the protocol requirements
Subject had signed informed consent
Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1
Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
Record of serum hemoglobin A1c within 90 days prior to the first treatment visit

Exclusion Criteria14

Subject is unable to comply with protocol treatment
Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.
Wagner 3, 4, or 5 involving tendon, bone, or joint.
Presence of systemic infection, sepsis, or osteomyelitis at screening.
Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
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 or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P 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 the first treatment visit; 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 enrollment
Index ulcer suspicious of neoplasm in the opinion of the principal investigator

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Interventions

OTHERNeoThelium FT (HCT/P 361)

NeoThelium FT (HCT/P 361) is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.