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

Venous Ulcer Clinical Trial

— LASERUVe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229330
• Other study ID #: 15-0634
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low-Level Light Therapy
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Procedure:
• Low-level Light Therapy
Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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