Clinical trial NCT02296697: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer
Low Level Laser Therapy
Dressings
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes on pressure ulcer area 28 days after first intervention
timeFrame: 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 outcomes:
measure: Changes on clinical evolution of the pressure ulcer 28 days after first intervention
timeFrame: 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.
measure: Changes on pressure ulcer relative area 28 days after first intervention
timeFrame: 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.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Graciele Sbruzzi, Dra
role: PRINCIPAL_INVESTIGATOR
References: