Electrical Stimulation of Cutaneous Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Electrical Stimulation of Cutaneous Lesions

Conditions
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Chronic Ulcer, Burns

Intervention / Treatment
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* Other: Control group
* Other: Treatment group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* This group will receive electrostimulation<br>* Other names: current stimulation;|
| Sham Comparator: Control group<br>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<br>* will be turn on the equipment, positioning the patient but no put intensity<br>* Other names: Sham group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical evaluation of the lesion | will be documented appearance of the wound | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, wound healing, Polarity current, Burn, Chronic ulcer