Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial

Abstract

BackgroundDifferent methods are available for the treatment of venous ulcers. Most current approaches focus on a combination of topical and compressive therapy. Adjuvant low-level laser therapy may be helpful in lesions with a protracted healing course, but evidence for its use is still limited. This paper describes the protocol of a randomized controlled trial designed to compare the effect of adjuvant low-level laser therapy versus conventional venous ulcer tissue repair, evaluated by a nurse using clinical indicators from the Nursing Outcomes Classification (NOC).Methods/designFor this prospective randomized controlled trial, 40 adult patients of both sexes with active venous ulcers will be recruited. Subjects will be selected by the sealed-envelope method without any annotation or external identification that might refer to the type of study group. At the time of unblinding, a label with the description of the group to which the patient belongs (that is, control or intervention) will be found inside the envelope. Conventional treatment (topical medication and compressive therapy) will be offered to both groups. Additionally, the intervention group will receive adjuvant low-level laser therapy. All patients will be followed weekly until ulcer healing or for a maximum of 16 weeks. Evaluation of tissue repair will be based on 14 clinical indicators drawn from NOC for wound healing (secondary intention) and tissue integrity (skin and mucous membranes). The primary endpoint will be decreased wound size and scar formation. This laser therapy is expected to enhance the quality, speed, and effectiveness of the treatment of venous ulcers, a chronic condition. This should reduce associated costs to the health service and allow patients to resume their daily activities sooner.DiscussionThis randomized clinical trial will use a validated method to investigate the effect of a novel intervention for the treatment of venous ulcers.Trial registrationClinicalTrials.gov, NCT03229330. Registered on July 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2729-x) contains supplementary material, which is available to authorized users.

Use of the Nursing Outcomes Classification - NOC to assess the knowledge of patients with venous ulcer

“…More than half the patients studied, as image 1 has shown, carried out actions to control the pathology. A Brazilian study evaluated the knowledge of patients about cardiac insufficiency and found better scores after a six-month follow-up (12) .…”

“…The sample of the study was made up of 38 patients with 78 VUs, from a Randomized Clinical Trial (RCT ) (7,12) that tested the LPLT as an adjunct treatment to the conventional one. During the RCT, patients were monitored in weekly nursing consultations, until they were discharged due to the scarring of the ulcer, or after 16 weeks of treatment had been completed.…”

Venous ulcer healing treated with conventional therapy and adjuvant laser: is there a difference?

“…This is a prospective cohort study guided by the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) (22) , aligned with an RCT (23) , conducted between April 2016 and February 2018, from which the patients for this study were derived (24) . The research was conducted at the specialized wound care outpatient clinic of the General Hospital of Porto Alegre, Rio Grande do Sul, Brazil, a reference in VU treatment and assists patients from different state regions.…”

“…The population was composed of patients with VU receiving treatment in the aforementioned hospital's outpatient clinic. The sample size calculation of the RCT, from which patients were derived for this study, considered the ability to detect a one-point difference in the Likert scale score of the NOC results, with 80% power and a 5% significance level (23)(24)(25) . Participated in the RCT 40 patients of both genders, aged 18 years or older, with current VU.…”

“…Therefore, laser therapy, specifically Low-Level Laser Therapy (LLLT), has been used as an adjuvant to conventional treatment to aid in wound tissue repair since it reduces the inflammatory process, favors recapillarization and neoformation of tissue layers, besides increasing collagen and elastic fibers in the healed area (13)(14)(15)(16) . In this perspective, some randomized studies show, through the evaluation of clinical indicators, tissue regeneration and reduction in the size of chronic lesions (vascular and diabetic) when using this type of adjuvant therapy to conventional treatment (17)(18)(19) .…”