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

Not Applicable

• Conditions: Pressure Ulcer
• Interventions: Device: Low-level laser therapy AlGaInP; Other: Wound dressing with saline solution; Device: High-frequency therapy with O3 formation

• Registration Number: NCT02296697
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-20
• Study Start: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-10
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-level laser therapy AlGaInP	Low-level laser therapy AlGaInP	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.
Wound dressing with saline solution	Wound dressing with saline solution	Wound dressing with hygiene of the pressure ulcer with warm saline and after applying the bandage will be held will be held.
High-frequency therapy with O3 formation	Wound dressing with saline solution	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.
Low-level laser therapy AlGaInP	Wound dressing with saline solution	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 therapy with O3 formation	High-frequency therapy with O3 formation	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.

Primary Outcome Measures

Name	Time	Method
Changes on pressure ulcer area 28 days after first intervention	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.	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

Name	Time	Method
Changes on clinical evolution of the pressure ulcer 28 days after first intervention	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.	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	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.	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.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil