- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02432859
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
July 29, 2015 updated by: giti torkaman, Tarbiat Modarres University
The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
-
Tehran, Iran, Islamic Republic of
- Tarbiat Modares University
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Electrical stimulation
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)
|
Direct current with sensory intensity for one hour
Other Names:
|
Placebo Comparator: Placebo
In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero
|
Direct current with zero intensity for one hour
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound surface area(cm2)
Time Frame: Change from Baseline in wound surface area at 2 and 4 weeks
|
Change from Baseline in wound surface area at 2 and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
April 16, 2015
First Submitted That Met QC Criteria
May 1, 2015
First Posted (Estimate)
May 4, 2015
Study Record Updates
Last Update Posted (Estimate)
July 31, 2015
Last Update Submitted That Met QC Criteria
July 29, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D52/2509
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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