Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC) (LASERUVe)
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ClinicalTrials.gov Identifier: NCT03229330 |
Recruitment Status :
Completed
First Posted : July 25, 2017
Last Update Posted : February 27, 2019
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Condition or disease | Intervention/treatment | Phase |
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Venous Ulcer Low-Level Light Therapy | Procedure: Low-level Light Therapy Combination Product: Conventional treatment | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | All subjects involved are aware of the procedures applied due to the features of the therapies used. |
Primary Purpose: | Treatment |
Official Title: | The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial |
Actual Study Start Date : | April 2016 |
Actual Primary Completion Date : | July 2018 |
Actual Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
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Experimental: 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.
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Procedure: Low-level Light Therapy
Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.
Other Names:
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
Other Name: Topical and compressive treatments |
Active Comparator: Controls
Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.
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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
Other Name: Topical and compressive treatments |
- 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.
- Skin thickness [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 16 weeks ]Overall improvement of the indicators of NOC results of Wound Healing: Second Intention and Tissue Integrity: Skin and Mucous Membranes.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229330
Brazil | |
Hospital de Clínicas de Porto Alegre | |
Porto Alegre, RS, Brazil, 90035-903 |
Principal Investigator: | Amália De Fátima Lucena | Hospital de Clínicas de Porto Alegre |
Responsible Party: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT03229330 |
Other Study ID Numbers: |
15-0634 |
First Posted: | July 25, 2017 Key Record Dates |
Last Update Posted: | February 27, 2019 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Wound Healing Outcome Assessment (Health Care) |
Varicose Ulcer Ulcer Pathologic Processes Varicose Veins Vascular Diseases |
Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |