RecruitingNot Applicable

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

United States10 participantsStarted 2025-08-26

Plain-language 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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Complete wound closure

Timeframe: 1-12 weeks

NCT IDNCT07039396

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-01

Angelina Ferguson, DNP

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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