<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/NCT03755960</url>
  </required_header>
  <id_info>
    <org_study_id>ACUDPN</org_study_id>
    <secondary_id>1/183/18</secondary_id>
    <nct_id>NCT03755960</nct_id>
  </id_info>
  <brief_title>ACUpuncture in Diabetic Peripheral Neuropathy</brief_title>
  <acronym>ACUDPN</acronym>
  <official_title>Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benno Brinkhaus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karl and Veronica Carstens Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in&#xD;
      patients with symptomatic peripheral diabetic neuropathy compared to routine care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will investigate the effect of a series of acupuncture treatments on subdimensions&#xD;
      of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of&#xD;
      the affected nerves are incorporated into the study as a possible morphological correlate of&#xD;
      functional and clinical findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2019</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</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>
    <intervention_model_description>multicenter, open label, randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The statistician will be blinded to the study intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue Scale (VAS) general complaints and pain</measure>
    <time_frame>8 weeks</time_frame>
    <description>Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neuropathic pain symptom inventory (NPSI )</measure>
    <time_frame>average of last 24h at baseline, 8, 16, 24 weeks</time_frame>
    <description>neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>-diabetic peripheral neuropathic pain Impact measure (DPNPI)</measure>
    <time_frame>average of last week at baseline, 8, 16, 24 weeks</time_frame>
    <description>disease- specific Quality of Life- max sum score of 95; the higher the sum-score the higher the interference of diabetic peripheral neuropathy with activities of daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form -12 (SF-12)</measure>
    <time_frame>baseline , 8 weeks</time_frame>
    <description>12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain perception Scale (SES german)</measure>
    <time_frame>latest average at 8, 16, 24 weeks</time_frame>
    <description>emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient global impression of Change (PGIC)</measure>
    <time_frame>8, 16 and 24 weeks</time_frame>
    <description>Scale from 1= very much improved to 7= very much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neurophysiological assessment of Nervus Suralis nerve conduction velocity</measure>
    <time_frame>baseline, 8,16 and 24 weeks</time_frame>
    <description>measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neurophysiological assessment of Nervus Suralis height of amplitude of action potential</measure>
    <time_frame>baseline, 8,16 and 24 weeks</time_frame>
    <description>height of amplitude of action potential of N. suralis in mikroVolt (µV) with device &quot;DPNCheck®&quot; from Neurometrix®</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Diabetic Neuropathy</condition>
  <arm_group>
    <arm_group_label>acupuncture plus routine care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 session of semistandardized acupuncture together with pharmacological routine care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>routine care alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks</description>
    <arm_group_label>acupuncture plus routine care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>routine care</intervention_name>
    <description>pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)</description>
    <arm_group_label>acupuncture plus routine care</arm_group_label>
    <arm_group_label>routine care alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria, among others:&#xD;
&#xD;
          -  Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2&#xD;
&#xD;
          -  Males and females aged &gt;18yrs &lt; 70yrs&#xD;
&#xD;
          -  Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)&#xD;
&#xD;
          -  Completed titration of pain medication against diabetic peripheral neuropathy&#xD;
&#xD;
          -  Pathological nerve conduction velocity and amplitude of N. suralis ( &lt;42meter/second&#xD;
             and or &lt; 6 mikroVolt)&#xD;
&#xD;
        Exclusion Criteria, among others:&#xD;
&#xD;
          -  Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg&#xD;
             muscles&#xD;
&#xD;
          -  Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol&#xD;
             toxic, or related to history of neurotoxic drugs.&#xD;
&#xD;
          -  Severe peripheral artery disease Fontaine stage IV&#xD;
&#xD;
          -  Ulcers or gangrenous lesions of the feet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benno Brinkhaus, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für TCM am UKE</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Weidenhammer W, Streng A, Linde K, Hoppe A, Melchart D. Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study. Complement Ther Med. 2007 Dec;15(4):238-46. doi: 10.1016/j.ctim.2006.09.005. Epub 2006 Oct 30.</citation>
    <PMID>18054725</PMID>
  </reference>
  <reference>
    <citation>Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x.</citation>
    <PMID>17355547</PMID>
  </reference>
  <reference>
    <citation>Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.</citation>
    <PMID>19420954</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Benno Brinkhaus</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>peripheral neuropathy</keyword>
  <keyword>diabetes mellitus type II</keyword>
  <keyword>neurophysiology</keyword>
  <keyword>nerve conduction velocity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
  </condition_browse>
  <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/NCT03755960
org study id: ACUDPN
secondary id: 1/183/18
nct id: NCT03755960
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in
      patients with symptomatic peripheral diabetic neuropathy compared to routine care.
The study will investigate the effect of a series of acupuncture treatments on subdimensions
      of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of
      the affected nerves are incorporated into the study as a possible morphological correlate of
      functional and clinical findings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: multicenter, open label, randomized
primary purpose: Treatment
masking: None (Open Label)
masking description: The statistician will be blinded to the study intervention.
measure: Visual analogue Scale (VAS) general complaints and pain
time frame: 8 weeks
description: Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain
measure: neuropathic pain symptom inventory (NPSI )
time frame: average of last 24h at baseline, 8, 16, 24 weeks
description: neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)
measure: -diabetic peripheral neuropathic pain Impact measure (DPNPI)
time frame: average of last week at baseline, 8, 16, 24 weeks
description: disease- specific Quality of Life- max sum score of 95; the higher the sum-score the higher the interference of diabetic peripheral neuropathy with activities of daily living.
measure: Short-Form -12 (SF-12)
time frame: baseline , 8 weeks
description: 12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living
measure: pain perception Scale (SES german)
time frame: latest average at 8, 16, 24 weeks
description: emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience.
measure: Patient global impression of Change (PGIC)
time frame: 8, 16 and 24 weeks
description: Scale from 1= very much improved to 7= very much worse
measure: neurophysiological assessment of Nervus Suralis nerve conduction velocity
time frame: baseline, 8,16 and 24 weeks
description: measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®
measure: neurophysiological assessment of Nervus Suralis height of amplitude of action potential
time frame: baseline, 8,16 and 24 weeks
description: height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix®
arm group label: acupuncture plus routine care
arm group type: Experimental
description: 12 session of semistandardized acupuncture together with pharmacological routine care
arm group label: routine care alone
arm group type: Active Comparator
description: pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
intervention type: Procedure
intervention name: acupuncture
description: semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks
arm group label: acupuncture plus routine care
intervention type: Drug
intervention name: routine care
description: pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
arm group label: acupuncture plus routine care
arm group label: routine care alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Benno Brinkhaus, MD, PhD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
facility: 
country: Germany
citation: Weidenhammer W, Streng A, Linde K, Hoppe A, Melchart D. Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study. Complement Ther Med. 2007 Dec;15(4):238-46. doi: 10.1016/j.ctim.2006.09.005. Epub 2006 Oct 30.
PMID: 18054725
citation: Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x.
PMID: 17355547
citation: Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.
PMID: 19420954
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Benno Brinkhaus
investigator title: Principal Investigator
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
sharing ipd: No