Abstract
BACKGROUND: Different 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/DESIGN: For 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. DISCUSSION: This randomized clinical trial will use a validated method to investigate the effect of a novel intervention for the treatment of venous ulcers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03229330 . Registered on July 2017.