Effect of Magnetic Current on Ulcer Healing

NCT06808191 · tracked via the Priya Life Science Egypt tracker

Sponsor

Beni-Suef University

Phase

Not applicable

Started

2025-02-01

Last updated

2025-02-05

Condition(s) studied

Diabetic Foot Ulcer

Investigational drug(s) / intervention(s)

pulsed electromagnetic currant machinePlacebo

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

Study 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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Eligibility

Sex

ALL

Min age

50 Years

Max age

65 Years

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.

Primary outcome measure(s)

ulcer size — 4 weeks
smart phone applications used to calculate wound size
Doppler ultrasonography — 4 weeks
used to calculate wound depth and microcirculation angiogenesis

Trial sites (1)

Facility	City	Region	Status
Beni-Suif University Hospital	Cairo	Cairo Governorate

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Other trials for the same condition

Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers Starting soon

The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer. Recruiting

High Tone External Muscle Stimulation on Diabetic Foot Ulcer Starting soon

RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808191 on ClinicalTrials.gov ↗ ← All trials in Egypt