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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus (DM)
• Intervention / Treatment: Procedure: Pulsed Electromagnetic Field Therapy and Ankle Range of Motion; Procedure: Ankle Range of Motion (Levangie and Norkin, 2011)

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Rubina Zulfqar; Phone Number: +923414291664; Email: drrubinazulfqar355@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Faisalabad, Punjab Province, Pakistan, 38000
      • Recruiting
      • Dr Rubina Zulfqar
      • Contact: Dr. Rubina Zulfqar; Phone Number: +923414291664; Email: drrubinazulfqar355@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Dorsiflexion; Plantarflexion; Inversion; Eversion Set 2 sets Repetition 15-20 repetition Workload 3 days/week (on alternate days) Total Treatment Period 6 weeks	Procedure: 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 Period 6 weeks
Experimental: Group B Ankle Range of Motion; 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 week
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.	6 weeks
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.	6 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: University of Faisalabad

Study record dates

Study Major Dates

• Study Start (Estimated): July 7, 2026
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: TUF/EIRB/174/26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No