Effect of Magnetic Current on Ulcer Healing

NCT ID: NCT06808191

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-08-01

Brief Summary

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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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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

pulsed electromagnetic currant machine

Intervention Type: 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.

Group B

20 patients will receive intervention by using the same PEMF unit, but the output will be shut off.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

control group will receive intervention by using the same PEMF unit, but the output will be shut off.

Interventions

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.

Intervention Type: DEVICE

Placebo

control group will receive intervention by using the same PEMF unit, but the output will be shut off.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Awad Ramadan Elkholy

lecturer of physical therapy for integumentary system disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

heba mohamed ali, Professor of Physical therapy

Role: STUDY_CHAIR

beni suif university

mahmoud awd elkholy, lecturer of physical therapy

Role: STUDY_DIRECTOR

beni suif university

asmaa ramadan kamel, physiotherapist

Role: PRINCIPAL_INVESTIGATOR

beni suif university

Locations

Beni-Suif University Hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Mahmoud awd elkholy, lecturer of physical therapy

Role: CONTACT

elkholym774@gmail.com

00201125746573

heba mohamed ali, Professor of Physical therapy

Role: CONTACT

elkholym774@gmail.com

00201006327885

Facility Contacts

mahmoud awd elkholy, lecturer

Role: primary

elkholym774@gmail.com

00201125746573

mahmoud awd elkholy, lecturer

Role: backup

0020115746573

References

Kwan RL, Cheing GL, Vong SK, Lo SK. Electrophysical therapy for managing diabetic foot ulcers: a systematic review. Int Wound J. 2013 Apr;10(2):121-31. doi: 10.1111/j.1742-481X.2012.01085.x. Epub 2012 Sep 7.

Reference Type: BACKGROUND

PMID: 22958779 (View on PubMed)

Other Identifiers

FMBSUREC/03032024/Kamel

Identifier Type: -

Identifier Source: org_study_id