The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Decreased Wound Size and Scar formation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
All subjects involved are aware of the procedures applied due to the features of the therapies used.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Low-level Light Therapy (Procedure)
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.
Intervention: Conventional treatment (Combination Product)
Controls
Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.
Intervention: Conventional treatment (Combination Product)
Outcomes
Primary Outcomes
Decreased Wound Size and Scar formation
Time Frame: 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 Outcomes
- Skin thickness(16 weeks)
- Evaluation of Pain(16 weeks)
- Overall improvement of other NOC indicators correlated.(16 weeks)