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Clinical Trials/NCT02432859
NCT02432859
Completed
N/A

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

Tarbiat Modarres University1 site in 1 country30 target enrollmentNovember 2013
ConditionsDiabetic Foot

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Tarbiat Modarres University
Enrollment
30
Locations
1
Primary Endpoint
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tarbiat Modarres University
Responsible Party
Principal Investigator
Principal Investigator

giti torkaman

Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity

Tarbiat Modarres University

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

Outcomes

Primary Outcomes

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 Outcomes

  • Wound surface area(cm2)(Change from Baseline in wound surface area at 2 and 4 weeks)

Study Sites (1)

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