<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/NCT01684839</url>
  </required_header>
  <id_info>
    <org_study_id>HB-TS-120127</org_study_id>
    <secondary_id>TSCHEN411206</secondary_id>
    <nct_id>NCT01684839</nct_id>
  </id_info>
  <brief_title>Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Tangshan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Qinhuangdao</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Second Hospital of Tangshan</source>
  <brief_summary>
    <textblock>
      Neuroma excision and digital nerve reconstruction remain the best option for the treatment of&#xD;
      Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional&#xD;
      nonvascularized nerve grafting is the primary option to bridge the defect. The investigators&#xD;
      hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital&#xD;
      nerve is better than conventional methods for reconstruction of the digital nerve defect&#xD;
      after painful neuroma resection.&#xD;
&#xD;
      This study reports treatment of painful digital neuroma using a pedicled nerve flap taken&#xD;
      from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the&#xD;
      patients had previous nerve injuries with or without nerve repair. The mechanisms of injury&#xD;
      include sharp cut, avulsion and crush. The defects were between the middle of the distal&#xD;
      phalanx and the palmar digital crease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our selection criteria in this study included a patient with PDN in a scarred wound bed or&#xD;
      poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital&#xD;
      crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm&#xD;
      in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve&#xD;
      defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb&#xD;
      neuroma. A finger with a small distal end of the digital nerve was also excluded, because&#xD;
      neurorrhaphy was extremely difficult in this situation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2010</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Static 2-point Discrimination Test</measure>
    <time_frame>20-26 months postoperatively</time_frame>
    <description>The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent &lt;6 mm; good 6-10 mm; fair 11-15 mm; poor &gt;15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cold Intolerance Severity Score (CISS) Questionnaire</measure>
    <time_frame>20-26 months postoperatively</time_frame>
    <description>The maximum score was 100 and was grouped into 4 ranges (0-25; 26-50; 51-75; and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tinel's Sign</measure>
    <time_frame>20-26 months postoperatively</time_frame>
    <description>Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Painful Digital Neuroma</condition>
  <arm_group>
    <arm_group_label>new surgical treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pedicled nerve flap</intervention_name>
    <description>This nerve flap is a vascularized nerve graft</description>
    <arm_group_label>new surgical treatment</arm_group_label>
    <other_name>Surgical flap</other_name>
    <other_name>Island flap</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a patient with PDN in a scarred wound bed or poor coverage&#xD;
&#xD;
          -  a PDN located between the middle of the distal phalanx and the palmar digital crease&#xD;
&#xD;
          -  a defect of the digital nerve after neuroma resection equal to or less than 3 cm in&#xD;
             length&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a PDN in healthy soft tissue&#xD;
&#xD;
          -  a digital nerve defect longer than 3 cm&#xD;
&#xD;
          -  injury to the course of the pedicle or the donor nerve&#xD;
&#xD;
          -  a thumb neuroma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gang Zhao, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>The Second Hospital of Tangshan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Hospital of Tangshan</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.</citation>
    <PMID>1262369</PMID>
  </results_reference>
  <results_reference>
    <citation>Tupper JW, Booth DM. Treatment of painful neuromas of sensory nerves in the hand: a comparison of traditional and newer methods. J Hand Surg Am. 1976 Sep;1(2):144-51. doi: 10.1016/s0363-5023(76)80008-1.</citation>
    <PMID>1032972</PMID>
  </results_reference>
  <verification_date>June 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>June 3, 2013</results_first_submitted>
  <results_first_submitted_qc>August 19, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 23, 2013</results_first_posted>
  <last_update_submitted>August 19, 2013</last_update_submitted>
  <last_update_submitted_qc>August 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Painful digital neuroma</keyword>
  <keyword>nerve defect</keyword>
  <keyword>dorsal branch of the digital nerve</keyword>
  <keyword>digital nerve</keyword>
  <keyword>pedicled nerve flap</keyword>
  <keyword>Pain Disorder Associated with Psychological and Physical Factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroma</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Nine patients were included in the study. These patients were treated with the pedicled nerve flap. The type of location was medical clinic.</recruitment_details>
      <pre_assignment_details>No wash out, run-in or transition happened in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>New Surgical Treatment</title>
          <description>Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>New Surgical Treatment</title>
          <description>Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.4" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Static 2-point Discrimination Test</title>
        <description>The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent &lt;6 mm; good 6-10 mm; fair 11-15 mm; poor &gt;15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.</description>
        <time_frame>20-26 months postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Surgical Treatment</title>
            <description>Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.</description>
          </group>
        </group_list>
        <measure>
          <title>Static 2-point Discrimination Test</title>
          <description>The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent &lt;6 mm; good 6-10 mm; fair 11-15 mm; poor &gt;15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cold Intolerance Severity Score (CISS) Questionnaire</title>
        <description>The maximum score was 100 and was grouped into 4 ranges (0-25; 26-50; 51-75; and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.</description>
        <time_frame>20-26 months postoperatively</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tinel's Sign</title>
        <description>Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma</description>
        <time_frame>20-26 months postoperatively</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>New Surgical Treatment</title>
          <description>Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Chao Chen</name_or_title>
      <organization>The Second Hospital of Tangshan</organization>
      <phone>86-13700350471</phone>
      <email>ts_chenchao@163.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01684839
org study id: HB-TS-120127
secondary id: TSCHEN411206
nct id: NCT01684839
lead sponsor: 
collaborator: 
collaborator: 
Neuroma excision and digital nerve reconstruction remain the best option for the treatment of
      Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional
      nonvascularized nerve grafting is the primary option to bridge the defect. The investigators
      hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital
      nerve is better than conventional methods for reconstruction of the digital nerve defect
      after painful neuroma resection.

      This study reports treatment of painful digital neuroma using a pedicled nerve flap taken
      from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the
      patients had previous nerve injuries with or without nerve repair. The mechanisms of injury
      include sharp cut, avulsion and crush. The defects were between the middle of the distal
      phalanx and the palmar digital crease.
Our selection criteria in this study included a patient with PDN in a scarred wound bed or
      poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital
      crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm
      in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve
      defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb
      neuroma. A finger with a small distal end of the digital nerve was also excluded, because
      neurorrhaphy was extremely difficult in this situation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Static 2-point Discrimination Test
time frame: 20-26 months postoperatively
description: The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.
measure: Cold Intolerance Severity Score (CISS) Questionnaire
time frame: 20-26 months postoperatively
description: The maximum score was 100 and was grouped into 4 ranges (0-25; 26-50; 51-75; and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
measure: Tinel's Sign
time frame: 20-26 months postoperatively
description: Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma
arm group label: new surgical treatment
arm group type: Other
description: Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
intervention type: Device
intervention name: Pedicled nerve flap
description: This nerve flap is a vascularized nerve graft
arm group label: new surgical treatment
other name: Surgical flap
other name: Island flap
criteria: 
gender: All
minimum age: 15 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gang Zhao, MD.
role: Study Chair
affiliation: The Second Hospital of Tangshan
facility: 
country: China
citation: Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.
PMID: 1262369
citation: Tupper JW, Booth DM. Treatment of painful neuromas of sensory nerves in the hand: a comparison of traditional and newer methods. J Hand Surg Am. 1976 Sep;1(2):144-51. doi: 10.1016/s0363-5023(76)80008-1.
PMID: 1032972
responsible party type: Sponsor
mesh term: Neuroma
mesh term: Pain
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 