Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06808191

Effect of Magnetic Current on Ulcer Healing

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.

:

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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):

  • Group A: Pulsed electromagnetic field (PEMF) group.
  • 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.

Outcome measures will include:

  • Wound closure.
  • Wound depth.
  • Microcirculation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. The ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound.
  • Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.
  • Wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons.

Exclusion criteria

  • 1- Ulcers secondary to non-diabetic etiology. 2- Poorly controlled diabetes. 3- Pregnancy. 4- Patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- Patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded.

6- Patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.

Treatment and study plan

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.

Primary outcomes

  1. ulcer size

    Time frame: 4 weeks

    smart phone applications used to calculate wound size

  2. Doppler ultrasonography

    Time frame: 4 weeks

    used to calculate wound depth and microcirculation angiogenesis

Study contacts

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

Mahmoud awd elkholy, lecturer of physical therapy

CONTACT

[email protected]

00201125746573

heba mohamed ali, Professor of Physical therapy

CONTACT

[email protected]

00201006327885

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot

Acronym: ulcer healing

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

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.

Published trials that share one or more normalized conditions with this study.