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

NCT ID: NCT02019082

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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electrical stimulation

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)

Group Type ACTIVE_COMPARATOR

Electrical Stimulation (BTL-5000 series, United Kingdom)

Intervention Type DEVICE

Direct current ES

placebo

In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DEVICE

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

Interventions

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Electrical Stimulation (BTL-5000 series, United Kingdom)

Direct current ES

Intervention Type DEVICE

placebo

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

Intervention Type DEVICE

Eligibility Criteria

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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,
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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giti torkaman

OTHER

Sponsor Role lead

Responsible Party

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giti torkaman

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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giti torkaman, PhD

Role: STUDY_DIRECTOR

professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity

Locations

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Physical Therapy Department, Faculty of Medical Sciences

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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د 50/259

Identifier Type: -

Identifier Source: org_study_id