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NCT Number: NCT02019082

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

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.

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Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Department, Faculty of Medical Sciences

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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,

Treatment and study plan

Electrical Stimulation (BTL-5000 series, United Kingdom)

Device

Direct current ES

PLACEBO

Device

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

Primary outcomes

  1. 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 outcomes

  1. skin temperature (degree of centigrade)

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

  2. skin temperature (degree of centigrade)

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

  3. skin temperature (degree of centigrade)

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

  4. Wound surface area(cm2)

    Time frame: on day 1, 12, and 26

Sponsors and collaborators

Lead sponsor

giti torkaman

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 24, 2013
Registry last updated
Dec 24, 2013

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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