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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02785497
Other study ID # U1111-1143-6541
Secondary ID
Status Completed
Phase N/A
First received May 28, 2013
Last updated May 26, 2016
Start date January 2010
Est. completion date May 2013

Study information

Verified date May 2016
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 59 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Control group
will be turn on the equipment, positioning the patient but no put intensity
Treatment group
This group will receive electrostimulation

Locations

Country Name City State
Brazil University of Sao Paulo Ribeirao Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Expert in evaluating healing images for a score Assessment to validate score in injury healing cutaneous Two years No
Primary clinical evaluation of the lesion will be documented appearance of the wound Two years No
Secondary standard photographic records of the wounds and quantification by digital software Assessment the wound area image for image j software and validate CAPAS software for the healing wound image by descriptors textures Two years No
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