- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02844660
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Central Research Associates
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Arizona
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Tucson, Arizona, Estados Unidos, 85710
- Arizona Regional Medical Research (ARMR)
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California
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Carlsbad, California, Estados Unidos, 92009
- ILD Research
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Fresno, California, Estados Unidos, 93710
- Limb Preservation Platform, Inc
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Los Angeles, California, Estados Unidos, 90057
- Foot and Ankle Clinic
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Florida
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Miami, Florida, Estados Unidos, 33143
- Doctors Research Network
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Georgia
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Augusta, Georgia, Estados Unidos, 30909
- Joseph M. Still Burn Center at Doctors Hospital
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic Foundation
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89119
- Advanced Foot & Ankle Center
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Pennsylvania
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Haverford, Pennsylvania, Estados Unidos, 19041
- Foot and Ankle Center
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Texas
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McAllen, Texas, Estados Unidos, 78501
- Futuro Clinical Trials
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Virginia
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Hampton, Virginia, Estados Unidos, 23666
- Ambulatory Foot & Ankle Center, PC
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Virginia Beach, Virginia, Estados Unidos, 23464
- Costal Podiatry
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
2. Index ulcer characteristics:
a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the randomization visit 3. Subject has completed 14-day run-in period with ≤ 30% wound area reduction post-debridement.
4. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR
- ABIs with results of ≥ 0.7 and ≤ 1.2, OR
Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot 5. Age ≥ 18 6. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Index Ulcer Assessment:
- Penetrates down totendon, or bone
- Presence of another diabetic foot ulcer within 3 cm of the index ulcer
- Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot
- Exhibits clinical signs and symptoms of infection
- Known or suspected local skin malignancy to the index diabetic ulcer
- Wound duration > one year without intermittent closure
Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
- In the last 7 days - Hyperbaric oxygen (HBO) therapy
- In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy
- In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
- In the last 30 days - study ulcer treatment with any biological skin substitutes, including EpiCord, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)
- In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
- In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot
Subject criteria that will make subject ineligible for enrollment:
- Known osteomyelitis or active cellulitis at wound site
- Hemoglobin A1C >12 in the last 60 days prior to randomization
- History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Known history of poor compliance with medical treatments
- Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited
- Subjects currently receiving radiation therapy or chemotherapy
- Patients currently on dialysis or planning to start dialysis
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 |
---|---|
Experimental: EpiCord
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
|
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
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Comparador activo: Standard of Care
Weekly application of moist wound therapy and offloading
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moist wound therapy and offloading
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Complete Ulcer Closure
Periodo de tiempo: 12 weeks
|
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
|
12 weeks
|
Study Safety Measurement
Periodo de tiempo: 12 weeks
|
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tiempo para completar el cierre
Periodo de tiempo: hasta 12 semanas
|
Según lo evaluado por la evaluación fotográfica y el Investigador
|
hasta 12 semanas
|
Tasa de cierre de heridas
Periodo de tiempo: hasta 12 semanas
|
Según lo evaluado por la evaluación fotográfica y el Investigador
|
hasta 12 semanas
|
Incidencia de recurrencia de úlcera
Periodo de tiempo: hasta 12 semanas
|
Incidencia de recurrencia de la úlcera en el sitio de la úlcera de estudio
|
hasta 12 semanas
|
Quality of Life Health Survey
Periodo de tiempo: up to 12 weeks
|
Change in quality of life metrics as measured by SF-36 Health Survey
|
up to 12 weeks
|
Quality of Life-Pain
Periodo de tiempo: up to 12 weeks
|
Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale
|
up to 12 weeks
|
Cost effectiveness of treatment
Periodo de tiempo: up to 12 weeks
|
Cost effectiveness of treatment regime.
looking at the number of grafts used on each study subject throughout the study.
|
up to 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William Tettelbach, MD, Intermountain Medical Center
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
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
- ECDFU001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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