Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation

Официальное название

Effect of Low Frequency Pulsed Electromagnetic Field Therapy on Vibration Perception Threshold and Protective Sensation in Diabetic Foot Ulcer

Обзор

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.

Вмешательства

• Процедура 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 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM * Dorsiflexion * Plantarflexion * Inversion * Eversion Set 2 sets Repetition 15-20 repetition Workload 3 days/week (on alternate days) Total Treatment P
• Процедура Ankle Range of Motion (Levangie and Norkin, 2011)
  Parameters Description Ankle Range of Motion Active ROM * Dorsiflexion * Plantarflexion * Inversion * Eversion (Levangie and Norkin, 2011) Set 2 sets Repetition 15-20 repetition Days/Week 3 days per week (on alternative days) Total Treatment Duration 6 weeks

Первичные конечные точки

• Vibration Perception Threshold [Срок оценки: 6 week]
• Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score). [Срок оценки: 6 weeks]
• Diabetic peripheral neuropathy [Срок оценки: 6 weeks]

Вторичные конечные точки (2)

• Range of Motion [Срок оценки: 6 weeks]
• Pain intensity [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Dr Rubina Zulfqar — Faisalabad

Идентификаторы

NCT: NCT07696728 · TUF/EIRB/174/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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