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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019082
• Other study ID #: ? 50/259
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: December 23, 2013
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2013
• Source: Tarbiat Modarres University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Electrical Stimulation (BTL-5000 series, United Kingdom)
Direct current ES
• placebo
the intervention procedure was the same as that the ES group, but the current intensity was zero

Locations

Country	Name	City	State
Iran, Islamic Republic of	Physical Therapy Department, Faculty of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
giti torkaman

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The plasma level of VEGF(pg/ml) and NO (microM)		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	No
Secondary	skin temperature (degree of centigrade)		prior the 1st electrical stimulation session (day 1) and 1 hour later	No
Secondary	skin temperature (degree of centigrade)		prior the 6th electrical stimulation session (day 12) and 1 hour later	No
Secondary	skin temperature (degree of centigrade)		prior the 12th electrical stimulation session (day 26) and 1 hour later	No
Secondary	Wound surface area(cm2)		on day 1, 12, and 26	No