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

Not Applicable

Completed

• Conditions: Low-Level Light Therapy; Venous Ulcer
• Interventions: Procedure: Low-level Light Therapy; Combination Product: Conventional treatment

• Registration Number: NCT03229330
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

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 Timeline

• Study Start: 2016-04
• Status Verified: 2017-07
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Primary Completion: 2018-07
• Study Completion: 2018-12
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Conventional treatment	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.
Intervention	Low-level Light Therapy	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.
Controls	Conventional treatment	Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Decreased Wound Size and Scar formation	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Skin thickness	16 weeks	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.
Evaluation of Pain	16 weeks	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.
Overall improvement of other NOC indicators correlated.	16 weeks	Overall improvement of the indicators of NOC results of Wound Healing: Second Intention and Tissue Integrity: Skin and Mucous Membranes.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil