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NCT Number: NCT07696728

Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation

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.

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Key information

Conditions

Diabetes Mellitus (DM) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Rubina Zulfqar

Faisalabad, Punjab Province, 38000, Pakistan

Location status: Recruiting

Location contact

Dr. Rubina Zulfqar

CONTACT

[email protected]

+923414291664

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Electromagnetic Field Therapy and Ankle Range of Motion

Procedure

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

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

Primary outcomes

  1. Vibration Perception Threshold

    Time frame: 6 week

    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.

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

    Time frame: 6 weeks

    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.

  3. Diabetic peripheral neuropathy

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Range of Motion

    Time frame: 6 weeks

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

  2. Pain intensity

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Rubina Zulfqar

CONTACT

[email protected]

+923414291664

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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