Diabetic Foot Ulcer
Conditions
Brief summary
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
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.
Interventions
DEVICEElectrical Stimulation (BTL-5000 series, United Kingdom)
Direct current ES
DEVICEplacebo
the intervention procedure was the same as that the ES group, but the current intensity was zero
Sponsors
giti torkaman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| skin temperature (degree of centigrade) | prior the 1st electrical stimulation session (day 1) and 1 hour later |
| Wound surface area(cm2) | on day 1, 12, and 26 |
Countries
Iran
Outcome results
None listed