xml: <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/NCT05985291</url>
    </required_header>
    <id_info>
      <org_study_id>23-817</org_study_id>
      <nct_id>NCT05985291</nct_id>
    </id_info>
    <brief_title>BurstDR Stimulation for Painful Diabetic Neuropathy</brief_title>
    <official_title>BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aurora Health Care</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aurora Health Care</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN)&#xD;
        patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with&#xD;
        conservative medical management per standard of care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 3, 2023</start_date>
    <completion_date type="Anticipated">October 3, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 3, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Average change from baseline to 3 months in treatment responder rates</measure>
      <time_frame>3 months</time_frame>
      <description>Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)</measure>
      <time_frame>6 months</time_frame>
      <description>0 no pain at all, 10 worse pain imaginable</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Percentage of patients with change from baseline in sensory neurological assessment at 3 months</measure>
      <time_frame>3 months</time_frame>
      <description>Assessed by the healthcare provider.</description>
    </other_outcome>
    <other_outcome>
      <measure>Average change from baseline to 3 months in severity of neuropathic pain as measured by Neuropathic Pain 4 Questions (DN4) (0-10)</measure>
      <time_frame>3 months</time_frame>
      <description>score of 4 or greater indicates neuropathic pain</description>
    </other_outcome>
    <other_outcome>
      <measure>Average change from baseline in CGM metrics from AGP report at 3 months</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Average change from baseline in health-related quality of life at 3 months as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29)</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Average change in proportion of remitters (remission is defined as having a lower limb pain Visual Analog Score score ≤ 2.5 cm) at 6 months</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Average change in health-related quality of life as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29) at 6 months</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Average change from baseline to 3 months in opioid dosage measured in total morphine milligram equivalents (MME)</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of participants with clinically meaningful improvement on sensory neurological examination as determined by the investigator at 6 months compared to baseline.</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Average change from baseline to 6 months in opioid dosage measured in total MME</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Average change from baseline to 6 months in severity of neuropathic pain as measured by DN4</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Difference in average percentage change from baseline in CGM metrics from AGP report at 6 months</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of subject outcomes satisfaction as measured through Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome) at 3 months and 6 months.</measure>
      <time_frame>3 &amp; 6 months</time_frame>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Painful Diabetic Neuropathy</condition>
    <arm_group>
      <arm_group_label>PDN treated with SCS and CMM</arm_group_label>
      <description>Painful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>SCS in combination with CMM</intervention_name>
      <description>Subjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care.</description>
      <arm_group_label>PDN treated with SCS and CMM</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will include patients older than 21 suffering from Painful Diabetic Neuropathy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at&#xD;
               least a year prior to signing the consent form&#xD;
  &#xD;
            -  PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and&#xD;
               capscaicin&#xD;
  &#xD;
            -  Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS)&#xD;
  &#xD;
            -  HbA1c ≤10%&#xD;
  &#xD;
            -  BMI &lt;45 kg/m2&#xD;
  &#xD;
            -  Be 22 years of age or older at the time of enrollment&#xD;
  &#xD;
            -  Be an appropriate candidate for the surgical procedures required in this study based&#xD;
               on the clinical judgment of the implanting physician&#xD;
  &#xD;
            -  Be capable of subjective evaluation, able to read and understand English-written&#xD;
               questionnaires, and able to read, understand and sign the written informed consent in&#xD;
               English&#xD;
  &#xD;
            -  Be willing and capable of giving informed consent&#xD;
  &#xD;
            -  Be willing and able to comply with study-related requirements, procedures, and&#xD;
               scheduled visits&#xD;
  &#xD;
            -  Have adequate cognitive ability to use a patient programmer and recharger as&#xD;
               determined by the Investigator&#xD;
  &#xD;
            -  Be on a stable analgesic regimen, as determined by the Investigator, for at least 30&#xD;
               days prior to assessing pain intensity, and be willing to stay on those medications&#xD;
               with no dose adjustments until activation of the permanently implanted SCS device&#xD;
  &#xD;
            -  Have stable neurological status measured by motor, sensory and reflex function as&#xD;
               determined by the investigator&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current daily opioid dosage greater than 120 mg morphine equivalents&#xD;
  &#xD;
            -  Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities&#xD;
               due to diabetic neuropathy at enrollment&#xD;
  &#xD;
            -  Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or&#xD;
               peroneal neuropathies), have had a lower limb amputation other than toes due to&#xD;
               diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.&#xD;
  &#xD;
            -  Have a current diagnosis of a progressive neurological disease such as multiple&#xD;
               sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive&#xD;
               arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome,Complex&#xD;
               Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial&#xD;
               plexus injury, as determined by the Investigator&#xD;
  &#xD;
            -  Have a current diagnosis or condition such as a coagulation disorder, bleeding&#xD;
               diathesis, platelet dysfunction, low platelet count, severely diminished functional&#xD;
               capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled&#xD;
               hypertension, progressive peripheral vascular disease or uncontrolled diabetes&#xD;
               mellitus that presents excess risk for performing the procedure, as determined&#xD;
               clinically by the Investigator&#xD;
  &#xD;
            -  Have prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral&#xD;
               nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic&#xD;
               intractable pain&#xD;
  &#xD;
            -  Be benefitting from an interventional procedure and/or surgery to treat lower limb&#xD;
               pain (Subjects should be enrolled at least 30 days from last benefit).&#xD;
  &#xD;
            -  Have an existing intrathecal pain pump and/or another active implantable device such&#xD;
               as a pacemaker&#xD;
  &#xD;
            -  Have a condition currently requiring or likely to require the use of diathermy or MRI&#xD;
               that is inconsistent with ProclaimTM system guidelines in the Physician's Manual&#xD;
  &#xD;
            -  Have either a metastatic malignant neoplasm or untreated local malignant neoplasm&#xD;
  &#xD;
            -  Have a life expectancy of less than one year&#xD;
  &#xD;
            -  Have a local infection at the anticipated surgical entry site or an active systemic&#xD;
               infection&#xD;
  &#xD;
            -  Have within 6 months of enrollment a significant untreated addiction to dependency&#xD;
               producing medications, alcohol or illicit drugs&#xD;
  &#xD;
            -  Be concomitantly participating in another clinical study&#xD;
  &#xD;
            -  Be involved in an injury claim under current litigation&#xD;
  &#xD;
            -  Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due&#xD;
               to chronic pain&#xD;
  &#xD;
            -  Have a pending or approved worker's compensation claim&#xD;
  &#xD;
            -  Have evidence of an active disruptive psychological or psychiatric disorder or other&#xD;
               known condition significant enough to impact perception of pain, compliance with&#xD;
               intervention and/or ability to evaluate treatment outcome, as determined by a&#xD;
               psychologist in the last 12 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mansoor Aman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aurora Healthcare</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Merve Buluk Figueira, MS</last_name>
      <phone>9204561551</phone>
      <email>merve.figueira@aah.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Aurora Health Oshkosh</name>
        <address>
          <city>Oshkosh</city>
          <state>Wisconsin</state>
          <zip>54914</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Merve Buluk Figueira, MS</last_name>
        <phone>920-456-1551</phone>
        <email>merve.figueira@aah.org</email>
      </contact>
      <investigator>
        <last_name>Mansoor Aman, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Vishal Patel, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lauren Lyons, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aurora Health Care</investigator_affiliation>
      <investigator_full_name>Mansoor Aman, MD</investigator_full_name>
      <investigator_title>Director, Interventional Pain Medicine- Oshkosh &amp; Fond du Lac</investigator_title>
    </responsible_party>
    <keyword>neurostimulation</keyword>
    <keyword>spinal cord stimulation</keyword>
    <keyword>burst stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Neuropathies</mesh_term>
      <mesh_term>Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data sharing with external institutions is not approved by the Aurora IRB.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985291
  org study id: 23-817
  nct id: NCT05985291
  lead sponsor: 
  has dmc: No
  is us export: No
  This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN)
        patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with
        conservative medical management per standard of care.
  observational model: Cohort
  time perspective: Prospective
  measure: Average change from baseline to 3 months in treatment responder rates
  time frame: 3 months
  description: Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS).
  measure: Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)
  time frame: 6 months
  description: 0 no pain at all, 10 worse pain imaginable
  measure: Percentage of patients with change from baseline in sensory neurological assessment at 3 months
  time frame: 3 months
  description: Assessed by the healthcare provider.
  measure: Average change from baseline to 3 months in severity of neuropathic pain as measured by Neuropathic Pain 4 Questions (DN4) (0-10)
  time frame: 3 months
  description: score of 4 or greater indicates neuropathic pain
  measure: Average change from baseline in CGM metrics from AGP report at 3 months
  time frame: 3 months
  measure: Average change from baseline in health-related quality of life at 3 months as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29)
  time frame: 3 months
  measure: Average change in proportion of remitters (remission is defined as having a lower limb pain Visual Analog Score score ≤ 2.5 cm) at 6 months
  time frame: 6 months
  measure: Average change in health-related quality of life as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29) at 6 months
  time frame: 6 months
  measure: Average change from baseline to 3 months in opioid dosage measured in total morphine milligram equivalents (MME)
  time frame: 3 months
  measure: Proportion of participants with clinically meaningful improvement on sensory neurological examination as determined by the investigator at 6 months compared to baseline.
  time frame: 6 months
  measure: Average change from baseline to 6 months in opioid dosage measured in total MME
  time frame: 6 months
  measure: Average change from baseline to 6 months in severity of neuropathic pain as measured by DN4
  time frame: 6 months
  measure: Difference in average percentage change from baseline in CGM metrics from AGP report at 6 months
  time frame: 6 months
  measure: Assessment of subject outcomes satisfaction as measured through Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome) at 3 months and 6 months.
  time frame: 3 & 6 months
  arm group label: PDN treated with SCS and CMM
  description: Painful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care.
  intervention type: Combination Product
  intervention name: SCS in combination with CMM
  description: Subjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care.
  arm group label: PDN treated with SCS and CMM
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mansoor Aman, MD
  role: Principal Investigator
  affiliation: Aurora Healthcare
  last name: Merve Buluk Figueira, MS
  phone: 9204561551
  email: merve.figueira@aah.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Aurora Health Care
  investigator full name: Mansoor Aman, MD
  investigator title: Director, Interventional Pain Medicine- Oshkosh & Fond du Lac
  mesh term: Diabetic Neuropathies
  mesh term: Pain
  sharing ipd: No
  ipd description: Data sharing with external institutions is not approved by the Aurora IRB.