Effect of Magnetic Current on Ulcer Healing

NCT06808191 | Not Yet Recruiting

• 1 other identifier: FMBSUREC/03032024/Kamel
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. :

Conditions

Diabetic Foot Ulcer

Keywords

ulcer diabetic magnetic

Outcome Measures

Primary Outcomes (2)

• ulcer size

  smart phone applications used to calculate wound size

  4 weeks

• Doppler ultrasonography

  used to calculate wound depth and microcirculation angiogenesis

  4 weeks

Study Arms (2)

group A

EXPERIMENTAL

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

Group B

PLACEBO COMPARATOR

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

Other: Placebo

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.

group A

Placebo OTHER

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

Group B

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suif University Hospital

Cairo, Cairo Governorate, 11865, Egypt

Location

Related Publications (1)

• 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.

  PMID: 22958779 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• heba mohamed ali, Professor of Physical therapy

  beni suif university

  STUDY CHAIR

• mahmoud awd elkholy, lecturer of physical therapy

  beni suif university

  STUDY DIRECTOR

• asmaa ramadan kamel, physiotherapist

  beni suif university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud awd elkholy, lecturer of physical therapy

CONTACT

00201125746573; elkholym774@gmail.com

heba mohamed ali, Professor of Physical therapy

CONTACT

00201006327885; elkholym774@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy for integumentary system disorders

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-12

Locations

EG (1)