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Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation

ConditionDiabetes Mellitus (DM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorUniversity of Faisalabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulsed Electromagnetic Field Therapy and Ankle Range of Motion

    Procedure/Surgery

    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 Period 6 weeks

  • Ankle Range of Motion (Levangie and Norkin, 2011)

    Procedure/Surgery

    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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Group A Pulsed Electromagnetic Field Therapy and Ankle Range of MotionExperimental treatment 1 intervention
Group B: Group B Ankle Range of MotionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Vibration Perception Threshold

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.

Time frame
6 week
2

Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).

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.

Time frame
6 weeks
3

Diabetic peripheral neuropathy

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.

Time frame
6 weeks

Secondary outcomes

1

Range of Motion

Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.

Time frame
6 weeks
2

Pain intensity

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.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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University of Faisalabad

Lead sponsor

Source ClinicalTrials.gov
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