Effect of Magnetic Current on Ulcer Healing

Sponsor
Beni-Suef University
Study ID
NCT06808191
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • pulsed electromagnetic currant machine — DEVICE
    Pulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 4weeks.
  • Placebo — OTHER
    control group will receive intervention by using the same PEMF unit, but the output will be shut off.

Study Details

This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group): 1- Group A: Pulsed electromagnetic field (PEMF) group. 2- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up. :

Key Dates

First listed
Feb 5, 2025
Start date
Feb 1, 2025
Status verified
Dec 2024
Primary completion
May 1, 2025
Completion
Aug 1, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group A
    Pulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 3weeks. 20 patients will remain in the study until the wound heals or 14 sessions will be completed, whichever came first
  • Placebo Comparator: Group B
    20 patients will receive intervention by using the same PEMF unit, but the output will be shut off.

Primary Outcome Measure

ulcer size [ Time Frame: 4 weeks ]

Central Contacts

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