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Completed

NCT Number: NCT02785497

Electrical Stimulation of Cutaneous Lesions

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.

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Key information

Conditions

Chronic Ulcer Burns Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

  • Infection
  • weight below 16kg

Treatment and study plan

Control Group

Other

will be turn on the equipment, positioning the patient but no put intensity

Other names: Sham group

treatment group

Other

This group will receive electrostimulation

Other names: Electrical stimulation, polar current, Current treatment, current stimulation

Primary outcomes

  1. clinical evaluation of the lesion

    Time frame: Two years

    will be documented appearance of the wound

Secondary outcomes

  1. standard photographic records of the wounds and quantification by digital software

    Time frame: Two years

    Assessment the wound area image for image j software and validate CAPAS software for the healing wound image by descriptors textures

Other outcomes

  1. Expert in evaluating healing images for a score

    Time frame: Two years

    Assessment to validate score in injury healing cutaneous

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 27, 2016
Registry last updated
May 27, 2016

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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