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Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers. (RESTORE)

17 de junio de 2026 actualizado por: Sequence LifeScience, Inc.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

Descripción general del estudio

Descripción detallada

This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing

Tipo de estudio

Intervencionista

Inscripción (Estimado)

2000

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • The potential subject must be at least 18 years of age or older.
  • The potential subject must agree to attend the weekly study visits required by the protocol.
  • The potential subject must be willing and able to participate in the informed consent process.
  • The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
  • At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device.
  • The potential subject has adequate off-loading of the ulcer

Exclusion Criteria:

  • The potential subject is known to have a life expectancy of < 3 months.
  • The potential subject's target ulcer is not a pressure ulcer.
  • The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
  • The target ulcer exposes tendon or bone.
  • The target ulcer has undermining or tunneling.
  • There is evidence of osteomyelitis complicating the target ulcer.
  • The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
  • The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
  • The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
  • The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length × width is acceptable).
  • The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC. - The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
  • The potential subject has end stage renal disease requiring dialysis.
  • The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
  • The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
  • The potential subject has a malnutrition indicator score of <17 as measured on the Mini Nutritional Assessment.
  • Known hemoglobin of < 8 g/dL as this is an indicator of poor wound healing.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Activate™ Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Experimental: AmnioDefend™ FT Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Experimental: Palisade™ DM Matrix + SOC
Two layers: amnion and chorion
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Experimental: Sentry™ SL Matrix + SOC
One layer: amnion
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Experimental: Shelter™ DM Matrix + SOC
Two layers: amnion and chorion
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Between Arm Difference for Complete Closure
Periodo de tiempo: 0-20 Weeks
Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.
0-20 Weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Closure
Periodo de tiempo: 0-20 Weeks
Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
0-20 Weeks
Percentage Area Reduction
Periodo de tiempo: 0-20 Weeks
Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.
0-20 Weeks
Pain Scale Reduction
Periodo de tiempo: 0-20 Weeks
Determine the between-arm difference in pain for patients that present with a Visual Analog Scale score of greater than 4. The scale is a rage of 0-10, 0 being no pain and 10 being worst pain imaginable.
0-20 Weeks
Adverse Events
Periodo de tiempo: 0-20 Weeks
Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.
0-20 Weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate Quality of Life
Periodo de tiempo: 0-20 Weeks
Evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC only using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, 12, 16, and 20.
0-20 Weeks
Compliance with Off-loading
Periodo de tiempo: 0-20 Weeks
To determine compliance with off-loading and the effect on wound closure.
0-20 Weeks
Ulcers to Close in Patients over 65
Periodo de tiempo: 0-20 Weeks
To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus mSOC.
0-20 Weeks
Rate of Reoccurrence
Periodo de tiempo: 0-20 Weeks
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
0-20 Weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Thomas Serena, MD, Serena Group

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de enero de 2026

Finalización primaria (Estimado)

28 de enero de 2028

Finalización del estudio (Estimado)

28 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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