Clinical trial NCT03229330: Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC)
Official title: The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcer
Low-Level Light Therapy
Keywords: Wound Healing
Outcome Assessment (Health Care)
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decreased Wound Size and Scar formation
timeFrame: 16 weeks
Secondary outcomes:
measure: Skin thickness
timeFrame: 16 weeks
measure: Evaluation of Pain
timeFrame: 16 weeks
measure: Overall improvement of other NOC indicators correlated.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Amália De Fátima Lucena
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bavaresco T, Pires AUB, Moraes VM, Osmarin VM, Silveira DT, Lucena AF. Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial. Trials. 2018 Jul 12;19(1):372. doi: 10.1186/s13063-018-2729-x.