Diabetic Foot
Conditions
Brief summary
The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.
Detailed description
30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.
Interventions
PROCEDUREElectrical Stimulation
Direct current with sensory intensity for one hour
PROCEDUREPlacebo
Direct current with zero intensity for one hour
Sponsors
Tarbiat Modarres University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Ischemic diabetic foot ulcer * Wagner classification DFU 2 * 0.5\<ABI\<0.9 * Mild to moderate diabetic neuropathy
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 wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml) | Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Wound surface area(cm2) | Change from Baseline in wound surface area at 2 and 4 weeks |
Countries
Iran
Outcome results
None listed