<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/NCT03020368</url>
  </required_header>
  <id_info>
    <org_study_id>Leeches for Rhizarthrosis</org_study_id>
    <nct_id>NCT03020368</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint</brief_title>
  <official_title>Effectiveness and Safety of Breeded Leech &quot;Medileech&quot; by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <brief_summary>
    <textblock>
      In this trial the investigators want to prove the efficacy and safety of a one-time topical&#xD;
      leech application at patients with symptomatic primary arthrosis of the first carpometacarpal&#xD;
      joint in comparison to the standard therapy with topical diclofenac.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>Change after 28 and 56 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale (VAS)</measure>
    <time_frame>Change after 7, 28 and 56 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication on demand</measure>
    <time_frame>Documentation between baseline and day 56</time_frame>
    <description>Documentation in daily diary</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Expectation</measure>
    <time_frame>Baseline</time_frame>
    <description>5-stage Likert scale for the expectation of symptomatic efficacy after group assignment</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall assessment of efficacy and tolerability</measure>
    <time_frame>Day 56</time_frame>
    <description>5-stage Likert scale documented by the patient as well as by the doctor at the end of the study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Rhizarthrosis</condition>
  <arm_group>
    <arm_group_label>Leeches</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One-time topical application of 2-3 leeches (&quot;medileech&quot;, Hirudo verbana) periarticularly on the painful thumb base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Leeches</intervention_name>
    <arm_group_label>Leeches</arm_group_label>
    <other_name>Hirudo verbana</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac</intervention_name>
    <arm_group_label>Diclofenac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 35 to 85 years&#xD;
&#xD;
          -  Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0&#xD;
             to 100 mm (relative to the last 24 hours)&#xD;
&#xD;
          -  Complaints for at least 3 months&#xD;
&#xD;
          -  X-ray Stadium Eaton I-IV at least once secured&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticoagulation (Marcumar, Heparin)&#xD;
&#xD;
          -  Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood&#xD;
             anomalies&#xD;
&#xD;
          -  Combination therapy of ASA and thienopyridines&#xD;
&#xD;
          -  Pain medication with opioid analgesics&#xD;
&#xD;
          -  Systemic medication with corticoids or immunosuppressants&#xD;
&#xD;
          -  Intraarterticular injections or RSO within the last 3 months&#xD;
&#xD;
          -  Past or planned surgery on the affected joint in the next 2 months&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Insulin-dependent type I diabetes mellitus&#xD;
&#xD;
          -  Acute psychotic disorders&#xD;
&#xD;
          -  Severe comorbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Michalsen, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
  </intervention_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/NCT03020368
org study id: Leeches for Rhizarthrosis
nct id: NCT03020368
lead sponsor: 
In this trial the investigators want to prove the efficacy and safety of a one-time topical
      leech application at patients with symptomatic primary arthrosis of the first carpometacarpal
      joint in comparison to the standard therapy with topical diclofenac.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
time frame: Change after 28 and 56 days
measure: Visual analog scale (VAS)
time frame: Change after 7, 28 and 56 days
measure: Medication on demand
time frame: Documentation between baseline and day 56
description: Documentation in daily diary
measure: Expectation
time frame: Baseline
description: 5-stage Likert scale for the expectation of symptomatic efficacy after group assignment
measure: Overall assessment of efficacy and tolerability
time frame: Day 56
description: 5-stage Likert scale documented by the patient as well as by the doctor at the end of the study
arm group label: Leeches
arm group type: Experimental
description: One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
arm group label: Diclofenac
arm group type: Active Comparator
description: 3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks
intervention type: Biological
intervention name: Leeches
arm group label: Leeches
other name: Hirudo verbana
intervention type: Drug
intervention name: Diclofenac
arm group label: Diclofenac
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andreas Michalsen, Prof. Dr.
role: Principal Investigator
affiliation: Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Diclofenac