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

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

No aplica

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

10 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Male or Female, 18 years of age or older
2. 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
3. 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.
4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
5. Subject is able and willing to follow the protocol requirements
6. Subject had signed informed consent
7. 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.
8. 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
9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.
10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit

Exclusion Criteria:

1. Subject is unable to comply with protocol treatment
2. 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.
3. Wagner 3, 4, or 5 involving tendon, bone, or joint.
4. Presence of systemic infection, sepsis, or osteomyelitis at screening.
5. Multiple DFUs on the same foot with \< 2 cm separation from the target ulcer.
6. 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.
7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
11. Subject is pregnant or breastfeeding
12. 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
13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (3)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

3 centros

Equipo y fechas

Patrocinador principal

NuScience Medical Biologics, LLC

Inicio del estudio

26 ago 2025 Real

Finalización primaria

22 may 2026 Real

Finalización del estudio

22 may 2026 Real

Primera publicación

26 jun 2025 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.