ReclutandoNCT06918561Registro de ClinicalTrials.gov

Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds

Open Wound

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

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: 132 Estimado

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

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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 chronic open wounds.

Leer la descripción completa

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 be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus NeoThelium FT.

The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to cross over to the IP arm (SOC plus NeoThelium FT). Crossover subjects will begin IP arm treatment with weekly NeoThelium FT applications for up to 12 treatment visits. 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. All subjects will complete two-week screening phase prior to being randomized into a treatment arm. Treatment arms will consist of NeoThelium FT in conjunction with standard of care, vs. standard of care alone. The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks. Secondary endpoints consist of wound percentage area reduction rates and pain assessment.

¿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 "other" Open wound
3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening
5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization
6. Subject has an Open wound without infection or clinically visible exposed bone
7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit
8. Index ulcer has a maximum depth of 1cm at screening visit 1
9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization
10. Adequate circulation of wounds located below the knee 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.
11. Index ulcer is free of infection prior to randomization and during screening phase.
12. Index ulcer is free of necrotic debris prior to NeoThelium FT application
13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization
14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
15. Subject is able and willing to follow the protocol requirements
16. Subject had signed informed consent
17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm

Exclusion Criteria:

1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than "open wound"
2. Subject has a known life expectancy of \<1 year
3. Subject is unable to comply with protocol treatment
4. 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.
5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
7. Known contraindications to tissue-engineered allograft
8. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
9. Subject is pregnant or breastfeeding
10. Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
12. Open wound with active infection
13. Wound depth with visible exposed bone
14. HBOT within 14 days prior to randomization
15. Revascularization surgery on the index wound leg within 30 days of screening phase
16. Index wound suspicious of neoplasm in the opinion of the principal investigator

Entiende la evaluación inicial

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: Asignación al azar
Enmascaramiento: Sin enmascaramiento

No Intervention: Standard of Care

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

Other: Standard of Care

Intervention: NeoThelium FT & Standard of Care

Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading

Other: NeoThelium FT

Standard of Care OTHER

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

NeoThelium FT OTHER

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.

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Complete Wound Closure

Plazo: 1-12 weeks

The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.

Medidas secundarias

Percentage Wound Area Change

Plazo: 1-12 weeks

The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.

Pain Assessment

Plazo: Day 0, Day 14, Day 35, Day 56, Day 84

Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points

Otras medidas

Adverse Events and Serious Adverse Events

Plazo: Day -14 through 91 days

The number and nature of adverse events (AEs) and series adverse events (SAEs) occurring during the study will be tracked and reported.

Follow-Up Closure

Plazo: 2 weeks

Number of wounds remaining closed during the 2-week follow-up

Time to Closure

Plazo: 1-12 weeks

Average number of grafts and/or weeks used to achieve wound closure

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (15)

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

Buscar un centro en este estudio

15 centros

MedCentris of Denham SpringsDenham Springs, Louisiana, United StatesReclutando

Tabatha YentCONTACTtabatha.yent@medcentris.com

Monique Consoer, NPPRINCIPAL_INVESTIGATOR

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Otras medidas

Centros de investigación (15)

Equipo y fechas

Contactos oficiales del estudio

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