<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/NCT03813758</url>
  </required_header>
  <id_info>
    <org_study_id>134-18-EMC</org_study_id>
    <nct_id>NCT03813758</nct_id>
  </id_info>
  <brief_title>Inter-observer and Intra-observer Variability of the Wrinkle Test</brief_title>
  <official_title>Inter-observer and Intra-observer Variability of the Wrinkle Test and the Optimum Time Need for the Test. Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</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>
      Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic&#xD;
      innervation. It is abolished by lesions affecting both central and peripheral sympathetic&#xD;
      pathways. It affords a simple and reliable clinical test of sympathetic function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon,&#xD;
      whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a&#xD;
      regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the&#xD;
      basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact&#xD;
      mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this&#xD;
      study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>
  <primary_outcome>
    <measure>wrinkle test</measure>
    <time_frame>40 min</time_frame>
    <description>wrinkle of the skin in the finger compaared to the finger witout digital nerve injury</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Wrinkle Test</condition>
  <arm_group>
    <arm_group_label>finger after digital nerve cut</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy finger</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>wrinkle test</intervention_name>
    <description>soaking in 40 deg water for 40 min. every 10 min the hand will be photo</description>
    <arm_group_label>finger after digital nerve cut</arm_group_label>
    <arm_group_label>healthy finger</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients after suture of full cut of digital nerve&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients after suture of full cut of digital nerve&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other nerve injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HaEmek medical center</name>
      <address>
        <city>Afula</city>
        <zip>18101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>guy rubin</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03813758
org study id: 134-18-EMC
nct id: NCT03813758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic
      innervation. It is abolished by lesions affecting both central and peripheral sympathetic
      pathways. It affords a simple and reliable clinical test of sympathetic function.
Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon,
      whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a
      regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the
      basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact
      mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this
      study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.
observational model: Case-Control
time perspective: Prospective
measure: wrinkle test
time frame: 40 min
description: wrinkle of the skin in the finger compaared to the finger witout digital nerve injury
arm group label: finger after digital nerve cut
arm group label: healthy finger
intervention type: Diagnostic Test
intervention name: wrinkle test
description: soaking in 40 deg water for 40 min. every 10 min the hand will be photo
arm group label: finger after digital nerve cut
arm group label: healthy finger
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: guy rubin
investigator title: MD
sharing ipd: No