Trial record 2 of 216408 for:    ALL

Electrical Stimulation of Cutaneous Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02785497
First received: May 28, 2013
Last updated: May 26, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Chronic Ulcer
Burns
Other: Control group
Other: Treatment group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Electrical Stimulation of Cutaneous Lesions

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • clinical evaluation of the lesion [ Time Frame: Two years ] [ Designated as safety issue: No ]
    will be documented appearance of the wound


Secondary Outcome Measures:
  • standard photographic records of the wounds and quantification by digital software [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Assessment the wound area image for image j software and validate CAPAS software for the healing wound image by descriptors textures


Other Outcome Measures:
  • Expert in evaluating healing images for a score [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Assessment to validate score in injury healing cutaneous


Enrollment: 60
Study Start Date: January 2010
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Other: Treatment group
This group will receive electrostimulation
Other Names:
  • Electrical stimulation
  • polar current
  • Current treatment
  • current stimulation
Sham Comparator: 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

Other: Control group
will be turn on the equipment, positioning the patient but no put intensity
Other Name: Sham group

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.
  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02785497

Locations
Brazil
University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rinaldo Guirro, PhD University of São Paulo
  More Information

Additional Information:
Responsible Party: Rinaldo Roberto de Jesus Guirro, PHD Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02785497     History of Changes
Other Study ID Numbers: U1111-1143-6541 
Study First Received: May 28, 2013
Last Updated: May 26, 2016
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Electrical stimulation
wound healing
Polarity current
Burn
Chronic ulcer

ClinicalTrials.gov processed this record on May 26, 2016