Effect of Magnetic Current on Ulcer Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pulsed electromagnetic currant machine, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: 50 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot
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. :
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.
Interventions
- Device 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. - Other Placebo
control group will receive intervention by using the same PEMF unit, but the output will be shut off.
Primary outcome measures
- ulcer size [Time frame: 4 weeks]
- Doppler ultrasonography [Time frame: 4 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Beni-Suif University Hospital — Cairo
Publications
- 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
Identifiers
NCT: NCT06808191 · FMBSUREC/03032024/Kamel