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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02296697
• Other study ID #: 140372
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: June 9, 2016
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Graciele Sbruzzi, Dra
• Phone: +55 51 94239420
• Email: graciele.sbruzzi[@]ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Low-level laser therapy AlGaInP
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.
• High-frequency therapy with O3 formation
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.

Other:
• Wound dressing with saline solution
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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.	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.	No
Secondary	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.	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.	No