Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

Patrocinadores

Patrocinador principal: Johns Hopkins University

Fuente Johns Hopkins University
Resumen breve

Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.

Descripción detallada

The purpose of this study is to identify emerging abnormal structural pathology of the vulnerable re-ulcerative diabetic foot incorporating physical therapy evaluation as well as the Noraxon gait analysis to generate quantitative and qualitative gait data. Once peak foot pressures and gait pathology is identified, gait remedy is fabricated including either a foot orthotic and/or an ankle foot prosthesis. Evaluation of constructed remedy will then be evaluated focusing on gait analysis data to validate decreased plantar foot peak pressures and gait realignment towards the reduction of the diabetic foot re-ulceration and subsequent foot or limb loss.

Estado general Recruiting
Fecha de inicio December 9, 2019
Fecha de Terminación December 6, 2023
Fecha de finalización primaria December 6, 2023
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of re-ulceration occurrences One year
Resultado secundario
Medida Periodo de tiempo
Number of major proximal amputation occurrences One year
Change of peak plantar pressure (n/cm^2) Every 3 months, up to one year
Change of length of gait (m) Every 3 months, up to one year
Location of amputation One year
Number of patients who remain in remission One year
Percentage of patients who do not experience re-ulceration after custom orthosis One year
Inscripción 69
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

Descripción: Physical therapy evaluation (range of motion, strength, mobility, scale). Noraxon based gait assessment on treadmill while barefoot and with instrumented inner soles. Over ground walking assessment (with wireless instrumented inner soles, observational gait analysis while climbing stairs, ramps, curbs). Noraxon gait assessment and walking on treadmill will be video recorded for assessment. Standard measure of functionality and 6 minute walk test will be conducted. Patient will be fitted with corrective orthotics, based on usual care. Physical therapy re-evaluation. Noraxon based gait assessment and foot assessment (any areas of irritation, callus formation, swelling, ulcer formation, and gait mobility irregularities will be monitored and reassessed) throughout the study.

Etiqueta de grupo de brazo: Noraxon myoRESEARCH™ Software

Elegibilidad

Criterios:

Inclusion Criteria:

- History of healed diabetic foot ulceration

- Over 18 years of age

Exclusion Criteria:

Patients who are:

- under 18 years of age

- non-diabetic

- non-ambulatory

- non-healed wounds.

Género: All

Edad mínima: 18 Years

Edad máxima: 90 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Ronald Sherman, DPM, MBA Principal Investigator Johns Hopkins University
Contacto general

Apellido: Priscilla Frost-Larity

Teléfono: 4109555165

Email: [email protected]

Ubicación
Instalaciones: Estado: Johns Hopkins Hospital
Ubicacion Paises

United States

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Noraxon myoRESEARCH™ Software

Tipo: Experimental

Descripción: All participants will be assigned to this group to receive study intervention.

Acrónimo NECRO
Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Descripción del modelo de intervención: Prospective, Single Center, Non-Randomized, Single treatment group

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov