Electrical Stimulation of Cutaneous Lesions

Not Applicable

Completed

• Conditions: Chronic Ulcer; Burns
• Interventions: Other: Control group; Other: Treatment group

• Registration Number: NCT02785497
• Lead Sponsor: University of Sao Paulo

Brief Summary

Skin lesions, such as chronic ulcers and burns, represent a serious public health problem due to high government costs, and scarce successful conservative treatments.There is a growing scientific literature on the use of electrotherapy in the process of wound healing, but in return there is a dearth of scientific studies on the use of various types of currents and the different parameters in the proposed treatments.

Detailed Description

This project proposes the use of polarized currents to increase the speed of healing in chronic ulcers and donor sites in burn patients. Will be included 30 patients with chronic ulcers and 30 burn patients undergoing skin graft surgery, will be randomized into control and treated groups. For the ulcer chronic group treatment will be with 50 minutes high voltage and 10 minutes diadynamica current and the burn group only 50 minutes high voltage current.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Study First Submitted: 2013-05-28
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-26
• Last Update Submitted: 2016-05-26
• Study First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all patients admitted to the rehabilitation center of Clinical Hospital with chronic ulcer, Faculty of Medicine of Ribeirão Preto / USP, in the period between january 2010 and december 2011
• all patients admitted to the Burns Unit of Clinical Hospital, Faculty of Medicine of Ribeirão Preto / USP, in the period between march 2011 and december 2012

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Exclusion Criteria

• Infection
• weight below 16kg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	For the control group the unit is turned on, the time will pass but will not be given intensity 50min, 100Hz, Intensity according to the sensitivity patient
Treatment group	Treatment group	Chronic ulcer patients will be treated with 50 minutes of the high-voltage current or 10 minutes of the diadynamic current. To burn patients 50 minutes high voltage current in the donor area. For both group the metal electrodes will be sterilized and the negative polarity in the active electrode. 50 min, 100Hz, intensity according to the sensitivity patient - High Voltage; 10 min, intensity according to the sensitivity patient - Diadynamic

Primary Outcome Measures

Name	Time	Method
clinical evaluation of the lesion	Two years	will be documented appearance of the wound

Secondary Outcome Measures

Name	Time	Method
standard photographic records of the wounds and quantification by digital software	Two years	Assessment the wound area image for image j software and validate CAPAS software for the healing wound image by descriptors textures

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil