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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04630704
Evaluating A Non-Invasive Tissue Perfusion Monitor
13 de noviembre de 2020 actualizado por: Pedra Technology, PTE LTD
A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
The Pedra perfusion system will be used to assess changes in perfusion in response to physiological stimuli.
It will be compared to other standard diagnostics.
Descripción general del estudio
Descripción detallada
The Pedra perfusion system measures microvascular flow through diffuse speckle contrast analysis.
It will be used to assess changes in perfusion in response to a number of physiological stimuli.
It will be compared to other standard diagnostics including ankle-brachial index, toe-brachial index and transcutaneous oxygen measurement.
Measurements will be undertaken in non-vascular patients as well as those with chronic limb threatening ischaemia.
Tipo de estudio
De observación
Inscripción (Anticipado)
50
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
40 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with palpable pulses and patients with chronic limb threatening ischaemia
Descripción
Inclusion Criteria:
CLTI cohort
- At least 40 years old
- Each patient will have documented arterial occlusive disease within 6 weeks of enrolment as determined by an ankle-brachial index (ABI) < 0.7 but not greater than 1.2, toe-brachial index (TBI) <0.5, skin perfusion pressure (SPP) less than 30mmHg, OR Transcutaneous oxygen measurement (TCOM) < 40mmHg in diabetics and <30mmHg in non-diabetics.
- The presence of skin breakdown compatible which with an underlying ischemic element (previous minor amputation for gangrene also included) that the Principle Investigator (PI) deems appropriate for the study.
- Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
Non-vascular group
- At least 40 years old
- Each patient will have documented palpable foot pulses
- 21 patients will be free of lower limb oedema and 6 patients will have moderate oedema present
- Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
Exclusion Criteria:
CLTI Cohort
- Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Age <40 or >90
- Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- Has smoked cigarettes/e-cigarettes on the day of testing.
- Has taken caffeine drinks on the day of testing
- In the last 3 hours the subject has exercised beyond normal daily walking.
- Inability to have TBI measured (e.g. absence of toe)
- Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
Non-vascular Cohort
- Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- Age <40 or >90
- Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- Has smoked cigarettes/e-cigarettes on the day of testing.
- Has taken caffeine drinks on the day of testing
- In the last 3 hours the subject has exercised beyond normal daily walking.
- Inability to have TBI measured (e.g. absence of toe)
- Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
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
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Non vascular repeatibility
This cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system
|
Diffuse speckle contrast analysis perfusion system
|
Non vascular physiology
This cohort of patients with palpable pulses will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
|
Diffuse speckle contrast analysis perfusion system
|
CLTI physiology
This cohort of patients with CLTI will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
|
Diffuse speckle contrast analysis perfusion system
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
Periodo de tiempo: Intra-procedure
|
The range of change in the Blood Perfusion Index (unitless) in response to physiologic changes in arterial perfusion, in patients with healthy circulation and those with compromised arterial circulation
|
Intra-procedure
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
Periodo de tiempo: intra-procedure
|
The reliability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
|
intra-procedure
|
Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
Periodo de tiempo: intra-procedure
|
The repeatability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
|
intra-procedure
|
Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets
Periodo de tiempo: Intra-procedure
|
Use of a ROC curve to assess the ability of the Blood Perfusion Index to differentiate between those with healthy circulation and those with arterial disease
|
Intra-procedure
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Anticipado)
7 de diciembre de 2020
Finalización primaria (Anticipado)
1 de abril de 2021
Finalización del estudio (Anticipado)
1 de julio de 2021
Fechas de registro del estudio
Enviado por primera vez
5 de noviembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
13 de noviembre de 2020
Publicado por primera vez (Actual)
16 de noviembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
13 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Pedra-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
No plan to share data
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.
Sí
producto fabricado y exportado desde los 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. .