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

giti torkaman

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Device: Electrical Stimulation (BTL-5000 series, United Kingdom); Device: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02019082

د 50/259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

electrical stimulation

Active Comparator group

Description:

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)

Treatment:

Device: Electrical Stimulation (BTL-5000 series, United Kingdom)

placebo

Placebo Comparator group

Description:

In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.

Treatment:

Device: placebo