Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation
NCT07696728 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-07-10
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.
Conditions
- Diabetes Mellitus (DM)
Interventions
- 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
- 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
Sponsors & Collaborators
-
University of Faisalabad
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-07
- Primary Completion
- 2026-08-05
- Completion
- 2026-08-05
Countries
- Pakistan
Study Locations
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