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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432859
• Other study ID #: D52/2509
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: July 29, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Tarbiat Modarres University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Procedure:
• Electrical Stimulation
Direct current with sensory intensity for one hour
• Placebo
Direct current with zero intensity for one hour

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tarbiat Modares University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tarbiat Modarres University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The wound fluid level of VEGF, VEGFR-2, HIF-1a and NO (pg/ml)		Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1a and NO at 4 weeks	No
Secondary	Wound surface area(cm2)		Change from Baseline in wound surface area at 2 and 4 weeks	No