<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/NCT03250403</url>
  </required_header>
  <id_info>
    <org_study_id>peripheral neuropathy PRP</org_study_id>
    <nct_id>NCT03250403</nct_id>
  </id_info>
  <brief_title>Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy</brief_title>
  <official_title>Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy: Double Blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP)&#xD;
      injection in the treatment of diabetic peripheral neuropathy compared to traditional medical&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide&#xD;
      clinical spectrum that encompasses generalized to focal and multifocal forms not only leads&#xD;
      to an impaired quality of life, but also to an increased morbidity and mortality . Till now&#xD;
      there is no available effective therapy for the treatment of diabetic peripheral neuropathy&#xD;
      (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides&#xD;
      necessary growth factors that promote wound healing/growth, angiogenesis, and axon&#xD;
      regeneration .&#xD;
&#xD;
      Objective: To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma&#xD;
      (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional&#xD;
      medical treatment.&#xD;
&#xD;
      Method : Prospective double blinded randomized controlled trial was conducted . All included&#xD;
      patients had type 2 DM selected from Endocrinology unit Department of Internal medicine,&#xD;
      Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients&#xD;
      with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies&#xD;
      ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure&#xD;
      were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score&#xD;
      (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were&#xD;
      double blindly divided into two groups, Group I underwent PRP preineural injection under&#xD;
      ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control&#xD;
      group) . Blood glucose was strictly controlled in both groups . Patients were followed every&#xD;
      month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means&#xD;
      ± standard deviation or frequencies. Independent Student's t test was done for comparison&#xD;
      between groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numbness</measure>
    <time_frame>6 months</time_frame>
    <description>modified Toronto Clinical Neuropathy Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain</measure>
    <time_frame>6 months</time_frame>
    <description>VAS 0-10 scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conduction velocity</measure>
    <time_frame>6 months</time_frame>
    <description>Meter/second</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>PRP injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>medical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRP injection</intervention_name>
    <description>peri-neural injection of platelet rich plasma</description>
    <arm_group_label>PRP injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional medical treatment</intervention_name>
    <description>traditional medical treatment</description>
    <arm_group_label>PRP injection</arm_group_label>
    <arm_group_label>medical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic peripheral neuropathy of at least 5 years duration of symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hereditary neuropathies , entrapment neuropathies , connective tissue diseases ,&#xD;
             vertebral diseases , thyroid disorders and end organ failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdelraheem M Alawaamy, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assuit University</name>
      <address>
        <city>Assiut</city>
        <zip>7111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Manal Hassanien</investigator_full_name>
    <investigator_title>Prenciple investigator</investigator_title>
  </responsible_party>
  <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>Undecided</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/NCT03250403
org study id: peripheral neuropathy PRP
nct id: NCT03250403
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP)
      injection in the treatment of diabetic peripheral neuropathy compared to traditional medical
      treatment.
Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide
      clinical spectrum that encompasses generalized to focal and multifocal forms not only leads
      to an impaired quality of life, but also to an increased morbidity and mortality . Till now
      there is no available effective therapy for the treatment of diabetic peripheral neuropathy
      (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides
      necessary growth factors that promote wound healing/growth, angiogenesis, and axon
      regeneration .

      Objective: To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma
      (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional
      medical treatment.

      Method : Prospective double blinded randomized controlled trial was conducted . All included
      patients had type 2 DM selected from Endocrinology unit Department of Internal medicine,
      Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients
      with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies
      ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure
      were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score
      (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were
      double blindly divided into two groups, Group I underwent PRP preineural injection under
      ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control
      group) . Blood glucose was strictly controlled in both groups . Patients were followed every
      month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means
      ± standard deviation or frequencies. Independent Student's t test was done for comparison
      between groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Numbness
time frame: 6 months
description: modified Toronto Clinical Neuropathy Score
measure: pain
time frame: 6 months
description: VAS 0-10 scale
measure: Conduction velocity
time frame: 6 months
description: Meter/second
arm group label: PRP injection
arm group type: Experimental
arm group label: medical treatment
arm group type: Active Comparator
intervention type: Drug
intervention name: PRP injection
description: peri-neural injection of platelet rich plasma
arm group label: PRP injection
intervention type: Other
intervention name: traditional medical treatment
description: traditional medical treatment
arm group label: PRP injection
arm group label: medical treatment
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Abdelraheem M Alawaamy, Dr
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Manal Hassanien
investigator title: Prenciple investigator
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
sharing ipd: Undecided