Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC) (LASERUVe)

The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial

This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.

Study Overview

• Status: Completed
• Conditions: Low-Level Light Therapy; Venous Ulcer
• Intervention / Treatment: Procedure: Low-level Light Therapy; Combination product: Conventional treatment

Detailed Description

There are several therapeutics with different mechanisms of action to reach tissue repair.

The conventional treatment of venous ulcers is based on the alternation of exercising the lower extremities with resting, the application of topical treatments associated with compressive therapy, and the use of medications.

Despite the diversity of bandages available, there are still lesions with difficult prolonged healing process. Therefore, Low-level Light Therapy has been used as an adjuvant technological alternative therapy, due to its photochemical effects on the tissues, such as the modulation of inflammation, increase of granulation tissue, contraction of the wound, reduction of the inflammatory process, and reduction of pain. This therapy contributes to accelerate and improve the tissue repair process.

Studies assessed by Nursing Outcomes Classification about the usage of the treatments above combined are not available. Consequently, more robust clinical studies over venous ulcers to evaluate the tissue repair must be proposed using reliable instruments.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of venous ulcer
• Availability for weekly appointment
• Acceptance to participate of the research with the signature of the Term of Free and Informed Consent

Exclusion Criteria:

• Morbid obesity
• Active cancer treatment
• Erysipelas
• Cellulitis, lymphangitis and chronic lymphedema
• Usage of immunosuppressants and / or corticosteroids
• Venous ulcer all around the leg
• Presence of coagulation necrosis covering more than 25% of the wound bed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Low-level Light Therapy: Wavelength of 660 nm (red laser) and Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.	Procedure: Low-level Light Therapy; Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.; Other Names: Wavelength of 660 nm; red laser; Combination product: Conventional treatment; Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress; Other Names: Topical and compressive treatments
Active Comparator: Controls; Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.	Combination product: Conventional treatment; Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress; Other Names: Topical and compressive treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased Wound Size and Scar formation	NOC Wound Healing: Second Intention - Greater length (in the cephalopheudial direction) versus greater width, in cm2 evaluated by the Likert scale, being 1 the worst score and 5 best score. NOC Wound Healing: Second Intention - Wound covered with epithelial tissue (new pink or bright tissue that develops from the edges or as "islands" on the surface of the lesion) evaluated by the Likert scale, being 1 the worst score and 5 best score.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin thickness	NOC Tissue Integrity: Skin and Mucous Membranes - Depth reached. It involves layers and structures of the skin altered by loss of tissue integrity (ulcerated area) assessed by the Likert scale, being 1 the worst score and 5 best score.	16 weeks
Evaluation of Pain	NOC Tissue Integrity: Skin and Mucous Membranes - Unpleasant sensory and emotional experience arising from actual or potential or described tissue injury, with sudden or slow onset of mild to severe intensity, constant or recurrent, without an anticipated or predictable termination. Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.	16 weeks
Overall improvement of other NOC indicators correlated.	Overall improvement of the indicators of NOC results of Wound Healing: Second Intention and Tissue Integrity: Skin and Mucous Membranes.	16 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Amália de Fátima Lucena, Hospital de Clínicas de Porto Alegre

Publications and helpful links

General Publications

• Bavaresco T, Pires AUB, Moraes VM, Osmarin VM, Silveira DT, Lucena AF. Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial. Trials. 2018 Jul 12;19(1):372. doi: 10.1186/s13063-018-2729-x.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Wound Healing; Outcome Assessment (Health Care)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: 15-0634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No