Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer

Tarbiat Modarres University

Status: Completed

Conditions: Diabetic Foot

Treatments: Procedure: Electrical Stimulation; Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02432859

D52/2509

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Electrical stimulation

Active Comparator group

Description:

In the 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:

Procedure: Electrical Stimulation

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:

Procedure: Placebo