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

G

giti torkaman

Status

Completed

Conditions

Diabetic Foot Ulcer

Treatments

Device: Electrical Stimulation (BTL-5000 series, United Kingdom)
Device: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02019082
د 50/259

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups, including a placebo group

electrical stimulation
Active Comparator group
Description:
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)
Treatment:
Device: Electrical Stimulation (BTL-5000 series, United Kingdom)
placebo
Placebo Comparator group
Description:
In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.
Treatment:
Device: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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