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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Venous Ulcer, Low-Level Light Therapy

Intervention / Treatment
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* Procedure: Low-level Light Therapy
* Combination Product: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Healing, Outcome Assessment (Health Care)