Electrical Stimulation of Cutaneous Lesions

NCT ID: NCT02785497

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Ulcer Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Treatment group

Intervention Type OTHER

This group will receive electrostimulation

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

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control group

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

Intervention Type OTHER

Treatment group

This group will receive electrostimulation

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sham group Electrical stimulation polar current Current treatment current stimulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rinaldo Roberto de Jesus Guirro

PHD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rinaldo Guirro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1143-6541

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PEMT Versus WBV on Quadriceps Strength Post Burn
NCT06525103 NOT_YET_RECRUITING NA