Low-Level Light Therapy, Venous Ulcer
Conditions
Keywords
Wound Healing, Outcome Assessment (Health Care)
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.
Interventions
PROCEDURELow-level Light Therapy
Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.
COMBINATION_PRODUCTConventional 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
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
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
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed