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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Electrical Stimulation
Placebo
Sponsored by
Tarbiat Modarres University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tarbiat Modares University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Electrical stimulation

Placebo

Arm Description

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)

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 wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)

Secondary Outcome Measures

Wound surface area(cm2)

Full Information

First Posted
April 16, 2015
Last Updated
July 29, 2015
Sponsor
Tarbiat Modarres University
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1. Study Identification

Unique Protocol Identification Number
NCT02432859
Brief Title
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Official Title
The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tarbiat Modarres University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical stimulation
Arm Type
Active Comparator
Arm Description
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)
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
Procedure
Intervention Name(s)
Electrical Stimulation
Other Intervention Name(s)
Direct current ES
Intervention Description
Direct current with sensory intensity for one hour
Intervention Type
Procedure
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Direct current ES
Intervention Description
Direct current with zero intensity for one hour
Primary Outcome Measure Information:
Title
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
Time Frame
Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary Outcome Measure Information:
Title
Wound surface area(cm2)
Time Frame
Change from Baseline in wound surface area at 2 and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Tarbiat Modares University
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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