Electrical Stimulation of Cutaneous Lesions

NCT02785497 | Completed DMC

• 1 other identifier: U1111-1143-6541
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Ulcer; Burns

Keywords

Electrical stimulation; wound healing; Polarity current; Burn; Chronic ulcer

Outcome Measures

Primary Outcomes (1)

• clinical evaluation of the lesion

  will be documented appearance of the wound

  Two years

Secondary Outcomes (1)

• standard photographic records of the wounds and quantification by digital software

  Two years

Other Outcomes (1)

• Expert in evaluating healing images for a score

  Two years

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

Control group OTHER

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

Also known as: Sham group

Control group

Treatment group OTHER

This group will receive electrostimulation

Also known as: Electrical stimulation, polar current, Current treatment, current stimulation

Treatment group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Infection
• weight below 16kg

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Burns

Interventions

Control Groups; Electric Stimulation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Physical Stimulation

Study Officials

• Rinaldo Guirro, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Professor

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 27, 2016
• Study Start: January 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

BR (1)