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

Официальное название

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

Обзор

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

Подробное описание

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 the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. 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.

Вмешательства

• Другое NeoThelium 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.

Первичные конечные точки

• Complete wound closure [Срок оценки: 1-12 weeks]

Вторичные конечные точки (4)

• Percentage Wound Area Change [Срок оценки: 1-12 weeks]
• Follow-Up Closure [Срок оценки: 2 weeks]
• Time to Closure [Срок оценки: 1-12 weeks]
• Hemoglobin A1c [Срок оценки: 1 week]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• MedCentris of Alexandria — Alexandria
• MedCentris of Leesville — Leesville
• MedCentris of Many — Many

Идентификаторы

NCT: NCT07039396 · NeoDia

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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