The Effect of Exercise on Wound Healing While Off-loading
15 de octubre de 2021 actualizado por: Deborah M. Wendland, Ph.D., Mercer University
The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer.
Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.
While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
15
Fase
- No aplica
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
- Nombre: Deborah M. Wendland, PhD
- Número de teléfono: 6785476775
- Correo electrónico: wendland_dm@mercer.edu
Copia de seguridad de contactos de estudio
- Nombre: Teri Biven, DPT
- Número de teléfono: 404.605.2743
- Correo electrónico: Teri.Biven@piedmont.org
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
- Reclutamiento
- Piedmont Healthcare
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Contacto:
- Teri Biven, DPT
- Número de teléfono: 404-605-2743
- Correo electrónico: Teri.Biven@piedmont.org
-
-
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Have diabetes
- Have an active plantar ulceration
- With or without peripheral neuropathy
- Able to safely exercise
- Receiving care for their plantar ulceration, including off-loading
Exclusion Criteria:
- Presence of an untreated infection, osteomyelitis, or gangrene
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise Added to Off-loading
Participants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions.
Wound care will continue at the facility as is standard, utilizing off-loading.
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Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact.
They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions.
These participants will also receive standard wound care with off-loading.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Wound measurement size
Periodo de tiempo: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
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Charts will be reviewed for normal wound measurements as is part of standard care.
Measurements are expected to be reported as surface area (cm^2) and/or volume (cm^3).
Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
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Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Summary of Diabetes Self-Care Activities Scale
Periodo de tiempo: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Participation in exercise.
Using two questions, this scale measures the number of days that an individual reports doing physical activity (question 1) or specific exercise (question 2).
Scores on each question could range from 0 to 7 days.
The higher the number, the more days the individual participates in the activity or exercise.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Body Mass Index
Periodo de tiempo: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Height and weight measurements will be combined and reported as BMI and measured in kg/m^2.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Physical activity data using an activity monitor (e.g. StepWatch).
Periodo de tiempo: Measured at baseline for one week.
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A week-long measurement of strides will be taken at the begin of the study.
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Measured at baseline for one week.
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Vibration sense
Periodo de tiempo: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Vibration sense will be measured using a Bio-Thesiometer to assess for degree of peripheral neuropathy.
A higher score would indicate decreased sensory perception of vibration.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Waist circumference
Periodo de tiempo: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Waist circumference will be taken in cm as a marker of body composition.
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Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Deborah M. Wendland, Mercer University
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)
14 de mayo de 2021
Finalización primaria (Anticipado)
1 de mayo de 2023
Finalización del estudio (Anticipado)
1 de mayo de 2023
Fechas de registro del estudio
Enviado por primera vez
19 de febrero de 2020
Primero enviado que cumplió con los criterios de control de calidad
19 de febrero de 2020
Publicado por primera vez (Actual)
21 de febrero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
15 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H1908192
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified closure rate data will be made available through a repository upon conclusion of the study and its dissemination.
Marco de tiempo para compartir IPD
Data will be available following the study conclusion and its dissemination (6 months after publication).
Criterios de acceso compartido de IPD
The information will be shared with researchers for meta-analyses through the data repository.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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
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