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This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.
Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were measured at 1st, 6th, and 12th session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electrical stimulation | Active Comparator | electrical stimulation group, group who received direct current ES at sensory threshold intensity for 1 h/day, 3 days/week, for 4 weeks (12 sessions) |
|
| placebo | Placebo Comparator | In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation (BTL-5000 series, United Kingdom) | Device | Direct current ES |
|
| Measure | Description | Time Frame |
|---|---|---|
| The plasma level of VEGF(pg/ml) and NO (microM) | prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later |
| Measure | Description | Time Frame |
|---|---|---|
| skin temperature (degree of centigrade) | prior the 1st electrical stimulation session (day 1) and 1 hour later | |
| skin temperature (degree of centigrade) | prior the 6th electrical stimulation session (day 12) and 1 hour later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| giti torkaman, PhD | professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Therapy Department, Faculty of Medical Sciences | Tehran | Iran |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| placebo | Device | the intervention procedure was the same as that the ES group, but the current intensity was zero |
|
| skin temperature (degree of centigrade) | prior the 12th electrical stimulation session (day 26) and 1 hour later |
| Wound surface area(cm2) | on day 1, 12, and 26 |
| 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 |