Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation
Effect of Low Frequency Pulsed Electromagnetic Field Therapy on Vibration Perception Threshold and Protective Sensation in Diabetic Foot Ulcer
Diabetes Mellitus (DM) is a chronic metabolic disorder characterized by hyperglycaemia for extended periods of time, which causes damage to peripheral nerves, resulting in sensory, motor and autonomic dysfunction. The study will aim to assess the effect of the Low pulse electromagnetic field therapy in VPT and protective sensation in the diabetic foot ulcer. The total number of participants will be 42 (calculated by epi tool) and the participants are to be divided among two groups. Non Probability Consecutive sampling technique will be used for this study.
The data collection tools will be Wagner Classification System for Diabetic Foot Ulcers, Numerical Pain Rating Scale, Goniometry, 10 g monofilament, Tuning Fork 128 Hz will be used. After meeting the inclusion and exclusion criteria and taking the written and verbal informed consent participants in one group will receive (low frequency pulsed electromagnatic field therapy and ankle Range of Motion) and other group will be receive (Sham PEMF and ankle Range of motion). Both interventions will be given three times weekly (or every other day) for 6 weeks. Vibrations perception, protective sensation, pain, ankle ROM and will be the outcome measures of the study. The data will be collected at baseline and 6 weeks. The data will be analyzed by using SPSS 23 and interpreted by using MS Word.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr. Rubina Zulfqar
- Número de teléfono: +923414291664
- Correo electrónico: drrubinazulfqar355@gmail.com
Ubicaciones de estudio
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Punjab Province
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Faisalabad, Punjab Province, Pakistán, 38000
- Reclutamiento
- Dr Rubina Zulfqar
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Contacto:
- Dr. Rubina Zulfqar
- Número de teléfono: +923414291664
- Correo electrónico: drrubinazulfqar355@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants must have a clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5) (Bolen et al., 2016).
- Patients with Wagner grade 1 diabetic foot ulcers was selected.
- Michigan Neuropathic Screening Instrument history score ≤7 (Viswanathan et al., 2025).
- Participants showing reduced vibration perception threshold on 128Hz Tunning fork was included to confirm the presence of sensory neuropathy Associated with diabetic ulcers (Viswanathan et al., 2025).
- Sensation on 10g monofilament less then 8 point out of 10 indicate reduces Sensation.
- Participants having diabetes for more than 10 years (Grewal et al., 2015).
- Pariticipants aged between 40 to 60 years.
- Both gender were included.
- Participants who was willing to give consent.
Exclusion Criteria:
- Participants who have significant cognitive impairment (e.g Dementia, Alzheimer) that would prevent them from understanding and adhering to Study instructions.
- Participants with active infections requiring systemic antibiotic therapy (Kwan et al., 2015).
- Patients with comorbidities such as malignancy, severe renal disease, or Other systemic condition.
- Participants who was not taking any medicine
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion
Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Table 2 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Experimental: Group B Ankle Range of Motion
Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Parameters Description Ankle Range of Motion Active ROM
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Vibration Perception Threshold
Periodo de tiempo: 6 week
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Vibration perception threshold will be measured by using Tuning Fork 128 Hz. that check either the patient sense the vibration or not.
if person feel sensation grater than 10 second indicate decrease vibration perception.
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6 week
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Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).
Periodo de tiempo: 6 weeks
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Protective sensation will be assessed using the 10-g monofilament at 10 standardized plantar sites.
One point is awarded for each site where the participant correctly perceives the monofilament, yielding a total score ranging from 0 to 10. Higher scores indicate better protective sensation.
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6 weeks
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Diabetic peripheral neuropathy
Periodo de tiempo: 6 weeks
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Diabetic peripheral neuropathy will be measured by using Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment, the decrease in score showed improvement the total score consisting of 5 per foot overall 10, 0 indicate foot is healthy and 10 indicate worse condition.
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6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Range of Motion
Periodo de tiempo: 6 weeks
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Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.
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6 weeks
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Pain intensity
Periodo de tiempo: 6 weeks
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Pain intensity will be measured by using Numerical Pain Rating Scale, the scale consisting of 0 to 10 number 0 means no pain 10 mean worse pain the decrease in NPRS scores reflecting decreased pain intensity and increased comfort.
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TUF/EIRB/174/26
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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