Effect of Magnetic Current on Ulcer Healing

N/ANot Yet RecruitingNCT06808191

Beni-Suef University40 enrolled

Overview

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. :

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

pulsed electromagnetic currant machineDEVICE

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.

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beni-Suif University Hospital

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

ulcer size

smart phone applications used to calculate wound size

Time frame: 4 weeks

Doppler ultrasonography

used to calculate wound depth and microcirculation angiogenesis

Time frame: 4 weeks

Central 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

Data from ClinicalTrials.gov

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