<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/NCT01724710</url>
  </required_header>
  <id_info>
    <org_study_id>201206038RIC</org_study_id>
    <nct_id>NCT01724710</nct_id>
  </id_info>
  <brief_title>To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast</brief_title>
  <official_title>To Study the Effect of Organic Light Emitting Diodes (OLED) on Cultured Fibroblast</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is&#xD;
      major reason leading to chronic wound healing.&#xD;
&#xD;
      The investigators's previous animal experiments have confirmed that OLED can promote burn&#xD;
      wound healing and fibroblast proliferation in normal Wistar rat.&#xD;
&#xD;
      In order to find the time point and dosage of the effective light therapy. The investigators&#xD;
      further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast&#xD;
      proliferation mechanisms.&#xD;
&#xD;
      Expect clinical application of light therapy in the future is more accurate and effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is&#xD;
      major reason leading to chronic wound healing.&#xD;
&#xD;
      Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted&#xD;
      therapy and photostimulation.&#xD;
&#xD;
      Although there are many treatments but no one has been widely accepted. The clinical effects&#xD;
      of uncertainty, high cost and inconvenience of use is the main reason.&#xD;
&#xD;
      Each year amputation of the population due to chronic ulcers has not decreased. In order to&#xD;
      break the current medical difficulties, We refer to the new light therapy technology.&#xD;
&#xD;
      Look forward to shorten the healing time and reduce medicine costs. The investigators's&#xD;
      previous animal experiments have confirmed that OLED can promote burn wound healing and&#xD;
      fibroblast proliferation in normal Wistar rat.&#xD;
&#xD;
      In order to find the time point and dosage of the effective light therapy. The investigators&#xD;
      further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast&#xD;
      proliferation mechanisms.&#xD;
&#xD;
      Expect clinical application of light therapy in the future is more accurate and effective&#xD;
      irradiative time points and dosage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Non-pressure Chronic Ulcer of Skin, Not Elsewhere Classified</condition>
  <arm_group>
    <arm_group_label>chronic ulcer</arm_group_label>
    <description>1x1cm2 tissue from chronic ulcer wound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal skin</arm_group_label>
    <description>1x1x0.1 cm3 normal skin from graft</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fibroblasts of Chronic ulcer and normal skin will be cultured. Fibroblast culture will be&#xD;
      analyzed with quantitative PCR.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. The process of collecting chronic ulcer skin: When the patient accept wound&#xD;
             debridement surgery, visiting staff will take 1x1cm2 skin of chronic ulcer.&#xD;
&#xD;
          2. The process of collecting normal skin: When the patient accept skin-grafting surgery,&#xD;
             visiting staff will take 1x1x0.1cm3 skin.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic ulcer&#xD;
&#xD;
          -  normal skin&#xD;
&#xD;
          -  age 50~80 years,&#xD;
&#xD;
          -  chronic skin ulcer patient&#xD;
&#xD;
          -  skin-grafting patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kean Eng Yeong, college</last_name>
    <role>Study Chair</role>
    <affiliation>NTUH Burn lab</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kean Eng Yeong, college</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>65648</phone_ext>
    <email>smartpace88@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kean Eng Yeong, college</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65648</phone_ext>
      <email>smartpace88@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01724710
org study id: 201206038RIC
nct id: NCT01724710
lead sponsor: 
has dmc: No
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is
      major reason leading to chronic wound healing.

      The investigators's previous animal experiments have confirmed that OLED can promote burn
      wound healing and fibroblast proliferation in normal Wistar rat.

      In order to find the time point and dosage of the effective light therapy. The investigators
      further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast
      proliferation mechanisms.

      Expect clinical application of light therapy in the future is more accurate and effective.
Chronic ulcers is a common clinical problem. Diabetes or peripheral vascular occlusion is
      major reason leading to chronic wound healing.

      Therapeutic methods to promote wound healing are hyperbaric oxygen therapy, vacuum assisted
      therapy and photostimulation.

      Although there are many treatments but no one has been widely accepted. The clinical effects
      of uncertainty, high cost and inconvenience of use is the main reason.

      Each year amputation of the population due to chronic ulcers has not decreased. In order to
      break the current medical difficulties, We refer to the new light therapy technology.

      Look forward to shorten the healing time and reduce medicine costs. The investigators's
      previous animal experiments have confirmed that OLED can promote burn wound healing and
      fibroblast proliferation in normal Wistar rat.

      In order to find the time point and dosage of the effective light therapy. The investigators
      further use cultured human fibroblasts in vitro to study light therapy to promote fibroblast
      proliferation mechanisms.

      Expect clinical application of light therapy in the future is more accurate and effective
      irradiative time points and dosage.
observational model: Case-Control
time perspective: Prospective
arm group label: chronic ulcer
description: 1x1cm2 tissue from chronic ulcer wound
arm group label: normal skin
description: 1x1x0.1 cm3 normal skin from graft
Fibroblasts of Chronic ulcer and normal skin will be cultured. Fibroblast culture will be
      analyzed with quantitative PCR.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kean Eng Yeong, college
role: Study Chair
affiliation: NTUH Burn lab
last name: Kean Eng Yeong, college
phone: 886-2-23123456
phone ext: 65648
email: smartpace88@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor