Back to results

Low-level Laser Therapy Versus High Frequency on Pressure Ulcers Treatment

Primary Purpose

Pressure Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Low-level laser therapy AlGaInP

High-frequency therapy with O3 formation

Wound dressing with saline solution

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring Pressure Ulcer, Low Level Laser Therapy, Dressings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pressure ulcers with rate II or III;
Not receiving pressure ulcer treatment.

Exclusion Criteria:

Presence of necrotic tissue needing debridement
Pregnancy
Discomfort during treatment
Pressure ulcers with area bigger than 30cm2
Extensive tunneling
Diabetes mellitus (DM)
Severe metabolic disease
Use of corticosteroids or vasopressors
Immunosuppression
Pacemaker
Neoplasia
Hemorrhage
Sensibility disorders
Metalic device.

Sites / Locations

Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low-level laser therapy AlGaInP

High-frequency therapy with O3 formation

Wound dressing with saline solution

Arm Description

AlGaInP 660 nm laser and dose of 6 J / cm 2 with point application on the edges of the lesion and sweep up application in the center.

High frequency generator, spherical electrode. Direct spark technique will be used, in which the electrode is positioned millimeters away from the skin of the patient, causing the formation of sparks, with increasing intensity up to 80 to 100% for ozone formation.

Wound dressing with hygiene of the pressure ulcer with warm saline and after applying the bandage will be held will be held.

Outcomes

Primary Outcome Measures

Changes on pressure ulcer area 28 days after first intervention

Evaluated through absolute (mm ²) reduction according to baseline. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.

Secondary Outcome Measures

Changes on clinical evolution of the pressure ulcer 28 days after first intervention

Clinical evolution of UP through PUSH score. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.

Changes on pressure ulcer relative area 28 days after first intervention

Evaluated through relative (%) reduction according to baseline. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.

Full Information

NCT ID

NCT02296697

First Posted

October 17, 2014

Last Updated

June 9, 2016

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT02296697

Brief Title

Low-level Laser Therapy Versus High Frequency on Pressure Ulcers Treatment

Official Title

Comparison Between the Effects of Low-level Laser Therapy, High Frequency and Wound Dressing on Pressure Ulcers Treatment: a Clinical Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Patients admitted in the Emergency Service that have pressure ulcers will be selected by eligibility criteria and randomized into three groups according to the adopted therapy: wound dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing + low-level laser therapy group (GLBP).

Detailed Description

Wound dressing is considered the standard treatment for pressure ulcers, however, despite its proven efficacy, it's a long-term healing process. Among Physiotherapy resources available for pressure ulcers treatment, the most used are low-level laser therapy and high-frequency generator. Even though the individual effects of both are evidenced on literature, there are no randomized clinical trials evidencing the effects of low-level laser therapy and high-frequency generator in comparison to wound dressing on pressure ulcers treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Ulcer

Keywords

Pressure Ulcer, Low Level Laser Therapy, Dressings

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low-level laser therapy AlGaInP

Arm Type

Active Comparator

Arm Description

AlGaInP 660 nm laser and dose of 6 J / cm 2 with point application on the edges of the lesion and sweep up application in the center.

Arm Title

High-frequency therapy with O3 formation

Arm Type

Active Comparator

Arm Description

Arm Title

Wound dressing with saline solution

Arm Type

Placebo Comparator

Arm Description

Wound dressing with hygiene of the pressure ulcer with warm saline and after applying the bandage will be held will be held.

Intervention Type

Device

Intervention Name(s)

Low-level laser therapy AlGaInP

Other Intervention Name(s)

Low-level laser therapy AlGaInP wavelength of 660 nm

Intervention Description

Pressure ulcers will be treated with AlGaInP 660 nm laser, wich will be used once a day, five days per week, dosed with 6 J/cm2. Laser therapy is applied punctually in each 1cm2 of the ulcer.

Intervention Type

Device

Intervention Name(s)

High-frequency therapy with O3 formation

Other Intervention Name(s)

High-frequency therapy with ozone formation

Intervention Description

High-frequency laser therapy will be applied with spherical electrode, wich contains neon gas inside, from a short distance from the pressure ulcer. The application will last 15 minutes, with increasing intensity from 80 to 100% for ozone formation, once a day, five days per week.

Intervention Type

Other

Intervention Name(s)

Wound dressing with saline solution

Intervention Description

Wound dressing will be done daily on patients from the three groups during the study period. On patients who will receive laser therapy and high frequency, the pressure ulcer will be sanitized with worm saline solution in order to clean the wound. This cleaning will be done before and after the interventions.

Primary Outcome Measure Information:

Title

Changes on pressure ulcer area 28 days after first intervention

Description

Time Frame

Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.

Secondary Outcome Measure Information:

Title

Changes on clinical evolution of the pressure ulcer 28 days after first intervention

Description

Clinical evolution of UP through PUSH score. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.

Time Frame

Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.

Title

Changes on pressure ulcer relative area 28 days after first intervention

Description

Time Frame

Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pressure ulcers with rate II or III; Not receiving pressure ulcer treatment. Exclusion Criteria: Presence of necrotic tissue needing debridement Pregnancy Discomfort during treatment Pressure ulcers with area bigger than 30cm2 Extensive tunneling Diabetes mellitus (DM) Severe metabolic disease Use of corticosteroids or vasopressors Immunosuppression Pacemaker Neoplasia Hemorrhage Sensibility disorders Metalic device.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Graciele Sbruzzi, Dra

Phone

+55 51 94239420

graciele.sbruzzi@ufrgs.br

First Name & Middle Initial & Last Name or Official Title & Degree

Fernanda M Balzan, Dra

Phone

+55 51 84281744

fbalzan@hcpa.ufrgs.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Graciele Sbruzzi, Dra

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035903

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Graciele Sbruzzi, Dra

Phone

0555194239420

graciele.sbruzzi@ufrgs.br

First Name & Middle Initial & Last Name & Degree

Fernanda M Balzan, Dra

First Name & Middle Initial & Last Name & Degree

Graciele Sbruzzi, Dra

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Low-level Laser Therapy Versus High Frequency on Pressure Ulcers Treatment

We'll reach out to this number within 24 hrs