Effect of Magnetic Current on Ulcer Healing (ulcer healing)

January 29, 2025 updated by: Mahmoud Awad Ramadan Elkholy, Beni-Suef University

Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot

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.

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Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Outcome measures will include:

  1. Wound closure.
  2. Wound depth.
  3. Microcirculation.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahmoud awd elkholy, lecturer of physical therapy
  • Phone Number: 00201125746573
  • Email: elkholym774@gmail.com

Study Contact Backup

  • Name: heba mohamed ali, Professor of Physical therapy
  • Phone Number: 00201006327885
  • Email: elkholym774@gmail.com

Study Locations

  • Egypt
    • القاهرة
      • Cairo, القاهرة, Egypt, 11865
        • Beni-Suif University Hospital
        • Contact:
        • Contact:
          • mahmoud awd elkholy, lecturer
          • Phone Number: 0020115746573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

    2. Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.

    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: pulsed electromagnetic currant machine
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 Comparator: Group B
20 patients will receive intervention by using the same PEMF unit, but the output will be shut off.
Other: Placebo
control group will receive intervention by using the same PEMF unit, but the output will be shut off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ulcer size
Time Frame: 4 weeks
smart phone applications used to calculate wound size
4 weeks
Doppler ultrasonography
Time Frame: 4 weeks
used to calculate wound depth and microcirculation angiogenesis
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Chair: heba mohamed ali, Professor of Physical therapy, beni suif university
  • Study Director: MAHMOUD AWD ELKHOLY, Lecturer of physical therapy, beni suif university
  • Principal Investigator: asmaa ramadan kamel, physiotherapist, beni suif university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/03032024/Kamel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

i dont know

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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