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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Hospital de Clinicas de Porto Alegre

Current Primary Outcome: Changes on pressure ulcer area 28 days after first intervention [ 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. ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes on clinical evolution of the pressure ulcer 28 days after first intervention [ 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. ]
    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 [ 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. ]
    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.


Original Secondary Outcome: Same as current

Information By: Hospital de Clinicas de Porto Alegre

Dates:
Date Received: October 17, 2014
Date Started: January 2015
Date Completion: December 2018
Last Updated: June 9, 2016
Last Verified: June 2016