Diabetic Foot Ulcer
Conditions
Keywords
ulcer diabetic magnetic
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. :
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
DEVICEpulsed 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.
OTHERPlacebo
control group will receive intervention by using the same PEMF unit, but the output will be shut off.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ulcer size | 4 weeks | smart phone applications used to calculate wound size |
| Doppler ultrasonography | 4 weeks | used to calculate wound depth and microcirculation angiogenesis |
Countries
Egypt
Contacts
Primary ContactMahmoud awd elkholy, lecturer of physical therapy
Backup Contactheba mohamed ali, Professor of Physical therapy
Outcome results
None listed