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

December 23, 2013 updated by: giti torkaman

The Effect of Low-intensity Direct Current on the Expression of Vascular Endothelial Growth Factor and Nitric Oxide in Diabetic Foot Ulcers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: electrical stimulation
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)
Device: Electrical Stimulation (BTL-5000 series, United Kingdom)
Direct current ES
Placebo Comparator: placebo
In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.
Device: placebo
the intervention procedure was the same as that the ES group, but the current intensity was zero

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The plasma level of VEGF(pg/ml) and NO (microM)
Time Frame: prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later
prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later

Secondary Outcome Measures

Outcome Measure
Time Frame
skin temperature (degree of centigrade)
Time Frame: prior the 1st electrical stimulation session (day 1) and 1 hour later
prior the 1st electrical stimulation session (day 1) and 1 hour later
skin temperature (degree of centigrade)
Time Frame: prior the 6th electrical stimulation session (day 12) and 1 hour later
prior the 6th electrical stimulation session (day 12) and 1 hour later
skin temperature (degree of centigrade)
Time Frame: prior the 12th electrical stimulation session (day 26) and 1 hour later
prior the 12th electrical stimulation session (day 26) and 1 hour later
Wound surface area(cm2)
Time Frame: on day 1, 12, and 26
on day 1, 12, and 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

giti torkaman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • د 50/259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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