Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients will return two weeks later for assessment.
Upon return, per the original protocol, patient would have been randomized at <20% closure; per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and all other eligibility criteria are met, the patient will be randomized (1:1) to receive either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.
All patients enrolled in this study will receive SOC. For the purposes of this study, Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will be applied after the wound has been debrided and hemostasis achieved. The wound will then be dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive dressing.
The patient will return once weekly for wound care, photographs and ulcer measurement. At each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon physician judgment. All patients complete their participation at Week 6.
This is an open label study and no attempt will be made to blind subjects or Investigators to randomization allocation.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85015
- Associated Foot and Ankle Specialists, LLC
-
-
California
-
Castro Valley, California, Estados Unidos, 94546
- Center for Clinical Research, Inc.
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Stockton, California, Estados Unidos, 95204
- Pacific Wound Center
-
-
Florida
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Jacksonville, Florida, Estados Unidos, 32216
- First Coast Cardiovascular Institute
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North Miami Beach, Florida, Estados Unidos, 33169
- Barry University Clinical Research
-
-
Massachusetts
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Plymouth, Massachusetts, Estados Unidos, 02360
- Beth Israel Deaconess Hospital - Plymouth
-
-
North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Goldsboro, North Carolina, Estados Unidos, 27533
- Wayne Memorial Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- an ambulatory person at least 18 years of age at the time of informed consent.
- type 1 or type 2 diabetes mellitus.
- glycosylated hemoglobin (HbA1c) of ≤12%
at least one wound that is/has:
- Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
- duration of at least 1 month,
- no clinical signs of infection or osteomyelitis,
- between 1cm2 and 25cm2 in area,
- per original protocol, closed <20% in area during the Screening Period; per Amendment #1, closed <30% in area during Screening and
- located on the foot, distal to malleoli.
- adequate circulation to the affected extremity
- serum creatinine of <3.0mg/dl.
Exclusion Criteria:
- participated in another clinical trial within 30 days prior to consent,
- Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
- receiving radiation or chemotherapy of any kind,
- known or suspected malignancy of current ulcer,
- pregnant or breast feeding,
- an active malignant disease,
- receiving hemo- or peritoneal dialysis,
- sickle cell anemia or Raynaud's syndrome,
- diagnosis of autoimmune connective tissue disease,
- received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
- exposed bone, tendon or joint capsule in the study ulcer,
- currently receiving antibiotics (for any reason), or
- taking medications considered to be immune system modulators.
Plan de estudios
¿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 |
|---|---|
|
Comparador activo: AMNIOEXCEL
Human Amniotic Membrane Allograft
|
Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
|
Comparador activo: Standard of Care, Diabetic Foot Ulcers
Advanced wound care dressings and offloading of wound.
|
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
Periodo de tiempo: 8 weeks
|
8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to complete wound closure of the target ulcer
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
|
Rate of wound closure
Periodo de tiempo: 8 Weeks
|
8 Weeks
|
|
|
Incidence, severity and type of adverse events
Periodo de tiempo: 8 Weeks
|
This outcome measure represents a composite of collected adverse event data.
|
8 Weeks
|
|
Changes in Quality of Life assessment
Periodo de tiempo: 8 Weeks
|
8 Weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Diabetes mellitus
- Úlceras del pie diabético
- Complicaciones de la diabetes
- Angiopatías diabéticas
- Herida
- Enfermedades del sistema endocrino
- Enfermedades de la piel
- Úlcera en la pierna
- Úlcera
- Úlcera de la piel
- Enfermedades de los pies
- Úlcera del pie
- Pie diabético
- Neuropatías diabéticas
- Salud del pie
- Úlceras en los pies de grado 1 o 2 de Wagner
- AMNIOEXCEL
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de la piel
- Enfermedades del sistema endocrino
- Angiopatías diabéticas
- Úlcera en la pierna
- Úlcera de la piel
- Complicaciones de la diabetes
- Diabetes mellitus
- Neuropatías diabéticas
- Enfermedades de los pies
- Pie diabético
- Úlcera del pie
- Úlcera
Otros números de identificación del estudio
- DS2014.01.01
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