<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/NCT01683500</url>
  </required_header>
  <id_info>
    <org_study_id>CCESWT01</org_study_id>
    <nct_id>NCT01683500</nct_id>
  </id_info>
  <brief_title>Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)</brief_title>
  <official_title>Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The&#xD;
      shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters&#xD;
      are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.&#xD;
&#xD;
        -  Trial with medical device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy&#xD;
      (medical device). The shock wave therapy will be done in 3 sessions with one week interval.&#xD;
      The outcome parameters are: change in pain (questionnaire), size of the calcinosis&#xD;
      (ultrasound and CT), new ulcers and intake of painkillers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in pain</measure>
    <time_frame>after 6 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Calcinosis Cutis in Connective Tissue Disease</condition>
  <arm_group>
    <arm_group_label>shock wave therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention: shock wave therapy with Modulith SLK (Storz)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>shock wave therapy with Modulith SLK (Storz)</intervention_name>
    <description>Three sessions with shock wave therapy, interval of one week.</description>
    <arm_group_label>shock wave therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age of 18&#xD;
&#xD;
          -  Calcinosis cutis due to connective tissue disease&#xD;
&#xD;
          -  information about ESWT given&#xD;
&#xD;
          -  Patient understands the study and signs the informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  No ESWT done&#xD;
&#xD;
          -  cuagulopathy&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  pace maker&#xD;
&#xD;
          -  severe disease in the opinion of the investigator&#xD;
&#xD;
          -  cardiac risk with NYHA III-IV&#xD;
&#xD;
          -  Ehlers-Danlos-Syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Blumhardt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Rheumatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Rheumatology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Connective Tissue Diseases</mesh_term>
    <mesh_term>Calcinosis Cutis</mesh_term>
    <mesh_term>Calcinosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683500
org study id: CCESWT01
nct id: NCT01683500
lead sponsor: 
has dmc: Yes
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The
      shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters
      are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.

        -  Trial with medical device
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy
      (medical device). The shock wave therapy will be done in 3 sessions with one week interval.
      The outcome parameters are: change in pain (questionnaire), size of the calcinosis
      (ultrasound and CT), new ulcers and intake of painkillers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in pain
time frame: after 6 weeks
arm group label: shock wave therapy
arm group type: Experimental
description: intervention: shock wave therapy with Modulith SLK (Storz)
intervention type: Device
intervention name: shock wave therapy with Modulith SLK (Storz)
description: Three sessions with shock wave therapy, interval of one week.
arm group label: shock wave therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandra Blumhardt, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Rheumatology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Connective Tissue Diseases
mesh term: Calcinosis Cutis
mesh term: Calcinosis