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

Tarbiat Modarres University30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Foot

Interventions

Electrical StimulationPROCEDURE

Direct current with sensory intensity for one hour

PlaceboPROCEDURE

Direct current with zero intensity for one hour

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tarbiat Modares University

Tehran, Iran

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)

Time frame: Change from Baseline in wound surface area at 2 and 4 weeks

Data from ClinicalTrials.gov

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