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Completed

NCT Number: NCT02432859

Electrical Stimulation and 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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarbiat Modares University

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulation

Procedure

Direct current with sensory intensity for one hour

Other names: Direct current ES

Placebo

Procedure

Direct current with zero intensity for one hour

Other names: Placebo Direct current ES

Primary outcomes

  1. 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

  1. Wound surface area(cm2)

    Time frame: Change from Baseline in wound surface area at 2 and 4 weeks

Sponsors and collaborators

Lead sponsor

Tarbiat Modarres University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 4, 2015
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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