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

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ClinicalTrials.gov Identifier: NCT02296697
Recruitment Status : Unknown
Verified June 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : November 20, 2014
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Low-level laser therapy AlGaInP Device: High-frequency therapy with O3 formation Other: Wound dressing with saline solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: 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 Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Low-level laser therapy AlGaInP wavelength of 660 nm

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.

Active Comparator: 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.
Device: 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 Name: High-frequency therapy with ozone formation

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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296697


Contacts
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Contact: Graciele Sbruzzi, Dra +55 51 94239420 graciele.sbruzzi@ufrgs.br
Contact: Fernanda M Balzan, Dra +55 51 84281744 fbalzan@hcpa.ufrgs.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Contact: Graciele Sbruzzi, Dra    0555194239420    graciele.sbruzzi@ufrgs.br   
Sub-Investigator: Fernanda M Balzan, Dra         
Principal Investigator: Graciele Sbruzzi, Dra         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Graciele Sbruzzi, Dra Hospital de Clínicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02296697    
Other Study ID Numbers: 140372
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Pressure Ulcer
Low Level Laser Therapy
Dressings
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases