The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tarbiat Modarres University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
Time Frame: Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary Outcomes
- Wound surface area(cm2)(Change from Baseline in wound surface area at 2 and 4 weeks)
Investigators
giti torkaman
Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity
Tarbiat Modarres University