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

Primary Purpose

Diabetic Foot Ulcer

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Electrical Stimulation (BTL-5000 series, United Kingdom)

placebo

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

Physical Therapy Department, Faculty of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

electrical stimulation

placebo

Arm Description

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)

In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.

Outcomes

Primary Outcome Measures

The plasma level of VEGF(pg/ml) and NO (microM)

Secondary Outcome Measures

skin temperature (degree of centigrade)

Wound surface area(cm2)

Full Information

NCT ID

NCT02019082

First Posted

October 9, 2013

Last Updated

December 23, 2013

Sponsor

giti torkaman

1. Study Identification

Unique Protocol Identification Number

NCT02019082

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

giti torkaman

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

electrical stimulation

Arm Type

Active Comparator

Arm Description

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)

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.

Intervention Type

Device

Intervention Name(s)

Electrical Stimulation (BTL-5000 series, United Kingdom)

Intervention Description

Direct current ES

Intervention Type

Device

Intervention Name(s)

placebo

Intervention Description

the intervention procedure was the same as that the ES group, but the current intensity was zero

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

skin temperature (degree of centigrade)

Time Frame

prior the 1st electrical stimulation session (day 1) and 1 hour later

Title

skin temperature (degree of centigrade)

Time Frame

prior the 6th electrical stimulation session (day 12) and 1 hour later

Title

skin temperature (degree of centigrade)

Time Frame

prior the 12th electrical stimulation session (day 26) and 1 hour later

Title

Wound surface area(cm2)

Time Frame

on day 1, 12, and 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

giti torkaman, PhD

Organizational Affiliation

professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity

Official's Role

Study Director

Facility Information:

Facility Name

Physical Therapy Department, Faculty of Medical Sciences

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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