<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229330</url>
  </required_header>
  <id_info>
    <org_study_id>15-0634</org_study_id>
    <nct_id>NCT03229330</nct_id>
  </id_info>
  <brief_title>Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC)</brief_title>
  <acronym>LASERUVe</acronym>
  <official_title>The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the effect of adjuvant treatment of Low-level Light Therapy with&#xD;
      conventional treatment in the tissue repair of venous ulcers in patients undergoing&#xD;
      outpatient nursing consultation. For the evaluation of the cases clinical indicators of&#xD;
      Nursing Outcomes Classification have been used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are several therapeutics with different mechanisms of action to reach tissue repair.&#xD;
&#xD;
      The conventional treatment of venous ulcers is based on the alternation of exercising the&#xD;
      lower extremities with resting, the application of topical treatments associated with&#xD;
      compressive therapy, and the use of medications.&#xD;
&#xD;
      Despite the diversity of bandages available, there are still lesions with difficult prolonged&#xD;
      healing process. Therefore, Low-level Light Therapy has been used as an adjuvant&#xD;
      technological alternative therapy, due to its photochemical effects on the tissues, such as&#xD;
      the modulation of inflammation, increase of granulation tissue, contraction of the wound,&#xD;
      reduction of the inflammatory process, and reduction of pain. This therapy contributes to&#xD;
      accelerate and improve the tissue repair process.&#xD;
&#xD;
      Studies assessed by Nursing Outcomes Classification about the usage of the treatments above&#xD;
      combined are not available. Consequently, more robust clinical studies over venous ulcers to&#xD;
      evaluate the tissue repair must be proposed using reliable instruments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>All subjects involved are aware of the procedures applied due to the features of the therapies used.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Decreased Wound Size and Scar formation</measure>
    <time_frame>16 weeks</time_frame>
    <description>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.&#xD;
NOC Wound Healing: Second Intention - Wound covered with epithelial tissue (new pink or bright tissue that develops from the edges or as &quot;islands&quot; on the surface of the lesion) evaluated by the Likert scale, being 1 the worst score and 5 best score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin thickness</measure>
    <time_frame>16 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Pain</measure>
    <time_frame>16 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall improvement of other NOC indicators correlated.</measure>
    <time_frame>16 weeks</time_frame>
    <description>Overall improvement of the indicators of NOC results of Wound Healing: Second Intention and Tissue Integrity: Skin and Mucous Membranes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Venous Ulcer</condition>
  <condition>Low-Level Light Therapy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low-level Light Therapy</intervention_name>
    <description>Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Wavelength of 660 nm</other_name>
    <other_name>red laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Conventional treatment</intervention_name>
    <description>Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Topical and compressive treatments</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of venous ulcer&#xD;
&#xD;
          -  Availability for weekly appointment&#xD;
&#xD;
          -  Acceptance to participate of the research with the signature of the Term of Free and&#xD;
             Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Morbid obesity&#xD;
&#xD;
          -  Active cancer treatment&#xD;
&#xD;
          -  Erysipelas&#xD;
&#xD;
          -  Cellulitis, lymphangitis and chronic lymphedema&#xD;
&#xD;
          -  Usage of immunosuppressants and / or corticosteroids&#xD;
&#xD;
          -  Venous ulcer all around the leg&#xD;
&#xD;
          -  Presence of coagulation necrosis covering more than 25% of the wound bed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amália De Fátima Lucena</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wound Healing</keyword>
  <keyword>Outcome Assessment (Health Care)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229330
org study id: 15-0634
nct id: NCT03229330
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: All subjects involved are aware of the procedures applied due to the features of the therapies used.
measure: Decreased Wound Size and Scar formation
time frame: 16 weeks
description: 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.
measure: Skin thickness
time frame: 16 weeks
description: 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.
measure: Evaluation of Pain
time frame: 16 weeks
description: 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.
measure: Overall improvement of other NOC indicators correlated.
time frame: 16 weeks
description: Overall improvement of the indicators of NOC results of Wound Healing: Second Intention and Tissue Integrity: Skin and Mucous Membranes.
arm group label: Intervention
arm group type: Experimental
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.
arm group label: Controls
arm group type: Active Comparator
description: Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.
intervention type: Procedure
intervention name: Low-level Light Therapy
description: Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.
arm group label: Intervention
other name: Wavelength of 660 nm
other name: red laser
intervention type: Combination Product
intervention name: Conventional treatment
description: Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress
arm group label: Controls
arm group label: Intervention
other name: Topical and compressive treatments
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amália De Fátima Lucena
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Ulcer
sharing ipd: Undecided