Diabetes Mellitus (DM)
Conditions
Brief summary
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.
Interventions
PROCEDUREPulsed 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
PROCEDUREAnkle 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
Sponsors
University of Faisalabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vibration Perception Threshold | 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. |
| Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score). | 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. |
| Diabetic peripheral neuropathy | 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
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 6 weeks | Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect. |
| Pain intensity | 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. |
Countries
Pakistan
Contacts
CONTACTDr. Rubina Zulfqar
Outcome results
None listed