Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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):
Outcome measures will include:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | 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 |
|
| Group B | Placebo Comparator | 20 patients will receive intervention by using the same PEMF unit, but the output will be shut off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed electromagnetic currant machine | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ulcer size | smart phone applications used to calculate wound size | 4 weeks |
| Doppler ultrasonography | used to calculate wound depth and microcirculation angiogenesis | 4 weeks |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud awd elkholy, lecturer of physical therapy | Contact | 00201125746573 | elkholym774@gmail.com | |
| heba mohamed ali, Professor of Physical therapy | Contact | 00201006327885 | elkholym774@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| heba mohamed ali, Professor of Physical therapy | beni suif university | Study Chair |
| mahmoud awd elkholy, lecturer of physical therapy | beni suif university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suif University Hospital | Cairo | Cairo Governorate | 11865 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22958779 | Result | 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. |
Not provided
Not provided
i dont know
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
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):
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | control group will receive intervention by using the same PEMF unit, but the output will be shut off. |
|
| asmaa ramadan kamel, physiotherapist |
| beni suif university |
| Principal Investigator |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |