<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/NCT03300531</url>
  </required_header>
  <id_info>
    <org_study_id>2017.N0.003</org_study_id>
    <nct_id>NCT03300531</nct_id>
  </id_info>
  <brief_title>Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease</brief_title>
  <official_title>Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Xingyue Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are&#xD;
      recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles&#xD;
      tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich&#xD;
      plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients&#xD;
      of case groups will receive P-PRP or PRP injection once a week for three times while the&#xD;
      control group received the same dose compound betamethasone injection. Follow up visit will&#xD;
      occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative&#xD;
      assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the&#xD;
      constant-murley score(CMS) and the rating scale of the American shoulder and elbow&#xD;
      surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation&#xD;
      methods is that the examination of MRI or ultrasound were accomplished before the first&#xD;
      injection and at 6 and 12 months afterwards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All injection will be done under ultrasound guidance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks, 12 weeks after intervention</time_frame>
    <description>Pain on activity will be evaluated by VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Constant-Murley Score(CMS)</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks, 12 weeks after intervention</time_frame>
    <description>Functional score of the shoulder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons (ASES) Shoulder Score</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks, 12 weeks after intervention</time_frame>
    <description>Functional score of the shoulder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand(DASH) Score</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks, 12 weeks after intervention</time_frame>
    <description>Functional score of the shoulder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)</measure>
    <time_frame>Baseline, 3 weeks, 6 weeks, 12 weeks after intervention</time_frame>
    <description>Functional score of the achilles tendon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>From baseline through study completion, an average of 3 year</time_frame>
    <description>Adverse events to evaluate the safety</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <condition>Lateral Epicondylitis</condition>
  <condition>Achilles Tendinitis</condition>
  <arm_group>
    <arm_group_label>P-PRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood will be drawn and pure platelet-rich plasma will be injected into the tendon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood will be drawn and platelet-rich plasma will be injected into the tendon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compound betamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) )</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection</intervention_name>
    <description>Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Pure platelet-rich plasma will be injected into the tendon.Once a week for three times.</description>
    <arm_group_label>P-PRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ultrasound-guided platelet-rich-plasma (PRP) injection</intervention_name>
    <description>Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Platelet-rich plasma will be injected into the tendon.Once a week for three times.</description>
    <arm_group_label>PRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultrasound-guided Compound betamethasone injection</intervention_name>
    <description>Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.</description>
    <arm_group_label>Compound betamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles&#xD;
             tendonitis;&#xD;
&#xD;
          2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation&#xD;
             treatment and other conservative treatment is invalid;&#xD;
&#xD;
          3. patient that can understand the clinical trials and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patient that underwent other injection treatment within 6 weeks&#xD;
&#xD;
          2. some associated diseases (such as arthritis, synovitis, entrapment of related nerve,&#xD;
             radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis,&#xD;
             pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive&#xD;
             reaction to bovine-derived proteins or fibrin glue)&#xD;
&#xD;
          3. patient that enrolled other clinical trials within 3 months&#xD;
&#xD;
          4. history of drug/alcohol addiction, habitual smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Weiliang Shen, Doctor</last_name>
    <phone>+86-13757101563</phone>
    <email>wlshen@zju.edu.cn</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pure Platelet-rich Plasma</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
  </intervention_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/NCT03300531
org study id: 2017.N0.003
nct id: NCT03300531
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are
      recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles
      tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich
      plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients
      of case groups will receive P-PRP or PRP injection once a week for three times while the
      control group received the same dose compound betamethasone injection. Follow up visit will
      occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative
      assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the
      constant-murley score(CMS) and the rating scale of the American shoulder and elbow
      surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation
      methods is that the examination of MRI or ultrasound were accomplished before the first
      injection and at 6 and 12 months afterwards.
All injection will be done under ultrasound guidance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
description: Pain on activity will be evaluated by VAS
measure: Constant-Murley Score(CMS)
time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
description: Functional score of the shoulder
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
description: Functional score of the shoulder
measure: The Disabilities of the Arm, Shoulder and Hand(DASH) Score
time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
description: Functional score of the shoulder
measure: Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)
time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
description: Functional score of the achilles tendon
measure: Adverse events
time frame: From baseline through study completion, an average of 3 year
description: Adverse events to evaluate the safety
arm group label: P-PRP
arm group type: Experimental
description: Blood will be drawn and pure platelet-rich plasma will be injected into the tendon.
arm group label: PRP
arm group type: Experimental
description: Blood will be drawn and platelet-rich plasma will be injected into the tendon.
arm group label: Compound betamethasone
arm group type: Active Comparator
description: 1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) )
intervention type: Biological
intervention name: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection
description: Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Pure platelet-rich plasma will be injected into the tendon.Once a week for three times.
arm group label: P-PRP
intervention type: Biological
intervention name: Ultrasound-guided platelet-rich-plasma (PRP) injection
description: Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Platelet-rich plasma will be injected into the tendon.Once a week for three times.
arm group label: PRP
intervention type: Drug
intervention name: Ultrasound-guided Compound betamethasone injection
description: Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.
arm group label: Compound betamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Weiliang Shen, Doctor
phone: +86-13757101563
email: wlshen@zju.edu.cn
responsible party type: Sponsor
mesh term: Tennis Elbow
mesh term: Tendinopathy
mesh term: Rotator Cuff Injuries
mesh term: Betamethasone
sharing ipd: No