Electrical Stimulation of Cutaneous Lesions

Burns Clinical Trial

Official title:

Electrical Stimulation of Cutaneous Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785497
• Other study ID #: U1111-1143-6541
• 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

• Burns
• Chronic Ulcer

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

External Links

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