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

• Published in: Current controlled trials in cardiovascular medicine 2018-07, Vol.19 (1), p.372-372, Article 372
• Main Authors: Bavaresco, Taline, Pires, Ananda Ughini Bertoldo, Moraes, Vítor Monteiro, Osmarin, Viviane Maria, Silveira, Denise Tolfo, Lucena, Amália de Fátima
• Format: Article
• Language: English
• Subjects: Activities of Daily Living; Analysis; Brazil; Care and treatment; Cellulitis; Chronic Disease; Clinical trials; Edema; Female; Humans; Intervention; Lasers; Lasers in surgery; Leg ulcers; Low-level light therapy; Low-Level Light Therapy - adverse effects; Male; Medical care, Cost of; Nursing; Nursing assessment; Nursing care; Nursing Staff, Hospital; Outcome and process assessment (Health Care); Outcome assessment (health care); Patients; Physiology; Prospective Studies; Randomized controlled trial; Randomized Controlled Trials as Topic; Recovery of Function; Standardized Nursing Terminology; Study Protocol; Time Factors; Tissue engineering; Treatment Outcome; Varicose ulcer; Varicose Ulcer - diagnosis; Varicose Ulcer - nursing; Varicose Ulcer - radiotherapy; Venous ulcer; Wound Healing
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2729-x

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). 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. This randomized clinical trial will use a validated method to investigate the effect of a novel intervention for the treatment of venous ulcers. ClinicalTrials.gov, NCT03229330 . Registered on July 2017.