Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Low-intensity Direct Current on the Expression of Vascular Endothelial Growth Factor and Nitric Oxide in Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Electrical Stimulation (BTL-5000 series, United Kingdom)
* Device: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wagner classification DFU 2; age 40-60 years; mild to moderate diabetic neuropathy; ABI>0.7 wound surface area>1.5cm2 Exclusion Criteria: fracture in a lower limb, a severe infection, a malignancy, kidney failure, skin diseases, osteomyelitis, pregnancy,

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: electrical stimulation<br>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) | Device: Electrical Stimulation (BTL-5000 series, United Kingdom)<br>* Direct current ES<br>|
| Placebo Comparator: placebo<br>In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero. | Device: placebo<br>* the intervention procedure was the same as that the ES group, but the current intensity was zero<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |