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

Not Applicable

Completed

• Conditions: Diabetic Foot
• Interventions: Procedure: Electrical Stimulation; Procedure: Placebo

• Registration Number: NCT02432859
• Lead Sponsor: Tarbiat Modarres University

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 Timeline

• Study Start: 2013-11
• Primary Completion: 2014-09
• Study Completion: 2015-02
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical stimulation	Electrical Stimulation	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)
Placebo	Placebo	In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Wound surface area(cm2)	Change from Baseline in wound surface area at 2 and 4 weeks

Trial Locations

Locations (1)

Tarbiat Modares University; 🇮🇷 Tehran, Iran, Islamic Republic of