Effect of Magnetic Current on Ulcer Healing (ulcer healing)

Beni-Suef University

Status: Not yet enrolling

Conditions: Diabetic Foot Ulcer

Treatments: Device: pulsed electromagnetic currant machine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06808191

FMBSUREC/03032024/Kamel

Details and patient eligibility

About

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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Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

group A

Experimental group

Description:

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

Treatment:

Device: pulsed electromagnetic currant machine

Group B

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo