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

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Venous Ulcer; Low-Level Light Therapy

Treatments: Combination Product: Conventional treatment; Procedure: Low-level Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03229330

15-0634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Procedure: Low-level Light Therapy

Combination Product: Conventional treatment

Controls

Active Comparator group

Description:

Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.

Treatment:

Combination Product: Conventional treatment