<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/NCT02236793</url>
  </required_header>
  <id_info>
    <org_study_id>BC1-CT4</org_study_id>
    <nct_id>NCT02236793</nct_id>
  </id_info>
  <brief_title>A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer</brief_title>
  <official_title>Phase III, Multicentre, Randomized, Parallel Group, Double Blinded and Control Group Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adocia</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Virchow Group</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Adocia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB&#xD;
      applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as&#xD;
      compared to Standard of Care alone for the treatment of neuropathic and neurovascular&#xD;
      diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile&#xD;
      normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB&#xD;
      will be applied on patients of the control group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of complete wound closure.</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to achieve complete wound closure.</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage reduction in total ulcer surface area at each visit.</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complete wound healing</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ulcer recurrence observed 12 weeks after wound healing.</measure>
    <time_frame>32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment emergent adverse events.</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">252</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>BioChaperone PDGF-BB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BioChaperone PDGF-BB administered every other day at the dose of 4µg/cm² for 20 weeks or until wound closure, associated with Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BioChaperone PDGF-BB</intervention_name>
    <arm_group_label>BioChaperone PDGF-BB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus&#xD;
&#xD;
          -  Patient with a single ulcer on the treated feet&#xD;
&#xD;
          -  Patient able and willing to provide informed consent&#xD;
&#xD;
          -  Patient able and willing to comply with protocol visits and procedure&#xD;
&#xD;
          -  Patient willing to use an off-loading method during the whole duration of the study&#xD;
&#xD;
          -  Full-thickness plantar, lateral or dorsal ulcer of the extremity (below the&#xD;
             malleolus), excluding inter-digits ulcer (web spaces), extending through the epidermis&#xD;
             and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined&#xD;
             by University of Texas Diabetic Wound Classification or Grade 1 according to Wagner&#xD;
             classification)&#xD;
&#xD;
          -  Chronic ulcer of at least six weeks despite appropriate wound care&#xD;
&#xD;
          -  Ulcer area measured with the formula Length x Width x 0.8 following sharp debridement,&#xD;
             of 1 to 10 cm², both inclusive&#xD;
&#xD;
          -  Well controlled infection or cellulitis (systemic antibiotherapy) before Baseline&#xD;
             Visit&#xD;
&#xD;
          -  Peripheral neuropathy as assessed by Semmes- Weinstein monofilament test or by the bio&#xD;
             esthesimeter (vibration perception threshold).&#xD;
&#xD;
          -  Ankle brachial pressure index &gt; 0.60 and &lt;1.3&#xD;
&#xD;
          -  Women surgically sterile, post-menopausal, or agree to practice adequate contraception&#xD;
             and have a negative pregnancy test at screening. Non-nursing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inter digit ulcers&#xD;
&#xD;
          -  Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores,&#xD;
             vascular ulcer or Charcot deformities ulcers&#xD;
&#xD;
          -  Charcot foot.&#xD;
&#xD;
          -  Wound originated from amputation bed&#xD;
&#xD;
          -  Active ulcer infection assessed by clinical examination and radiography if necessary.&#xD;
             Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement&#xD;
             and controlled by standard wound care.&#xD;
&#xD;
          -  Active osteomyelitis affecting the area of the target ulcer&#xD;
&#xD;
          -  Poorly controlled diabetes (uncontrolled glycemia: HbA1c% &gt;= 10%), renal failure&#xD;
             (serum creatinine &gt; 3.0 mg/dL), poor nutritional status (albumin &lt; 3.0 g/dL or total&#xD;
             protein &lt; 6.5 g/dL)&#xD;
&#xD;
          -  Known connective tissue or malignant disease&#xD;
&#xD;
          -  Concomitant treatment with corticosteroids, immunosuppressive agents, radiation&#xD;
             therapy, or anticancer chemotherapy&#xD;
&#xD;
          -  Use of investigational drug/device or growth factor within 30 days&#xD;
&#xD;
          -  Topical application of any advance wound care on this wound (antiseptics, antibiotics,&#xD;
             debriders, enzyme) within 7 days&#xD;
&#xD;
          -  Vascular reconstruction within 8 weeks&#xD;
&#xD;
          -  Patients expected to be noncompliant with the protocol (not available for the duration&#xD;
             of the trial, treatment or wound care compliance), or felt to be unsuitable by the&#xD;
             Investigator for any other reason.&#xD;
&#xD;
          -  A history of severe cerebrovascular events&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arun Bal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SL Raheja Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mediciti Hospital</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500 063</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SL Raheja Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.V. Hospital for Diabetes (P) Ltd</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre</name>
      <address>
        <city>Chennai</city>
        <state>Taminadu</state>
        <zip>600 029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>B.J. Medical College and Civil Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Jivraj Mehta Smarak Health Foundation</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sangini Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V.S. General Hospital &amp; Sml NHL Municipal Medical College Sheth</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rajiv Gandhi Centre for Diabetes and Endocrinology</name>
      <address>
        <city>Aligarh</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Govt Medical College and Hospital</name>
      <address>
        <city>Chandigarh</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sri Ramachandra Medial Centre</name>
      <address>
        <city>Chennai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Madras Diabetes Research Foundation</name>
      <address>
        <city>Chennai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Madras Medical Mission</name>
      <address>
        <city>Chennai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gandhi Medical College &amp; Hospital</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizam's Institute of Medical Sciences</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sumana Hospital</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surakshaka diabetic Centre(P) Ltd</name>
      <address>
        <city>Hyderabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMS Medical College &amp; Attached Hospital</name>
      <address>
        <city>Jaipur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ILS Hospital</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPGME &amp; R and SSKM Hospital</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nightingale Hospital</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabindranath Tagore International Insitute of cardiac Sciences</name>
      <address>
        <city>Kolkata</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fortis Hospital Phase</name>
      <address>
        <city>Mohali</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seth G.S. Medical College and K.E.M Hospital</name>
      <address>
        <city>Mumbai</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mysore Medical College &amp; Research Institute</name>
      <address>
        <city>Mysore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Govt Medical college &amp; Hospital Medical Square</name>
      <address>
        <city>Nagpur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indira Gandhi Govt Medical College and Hospital</name>
      <address>
        <city>Nagpur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>B.J. Govt. Medical College and Sassoon Hospital</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inamdar Multispeciality Hospital</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poona Hospital &amp; Research Centre</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shree Giriraj Multispeciality Hospital</name>
      <address>
        <city>Rajkot</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Georges Hospital</name>
      <address>
        <city>Vishakapatnam</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>June 28, 2017</last_update_submitted>
  <last_update_submitted_qc>June 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Becaplermin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02236793
org study id: BC1-CT4
nct id: NCT02236793
lead sponsor: 
collaborator: 
has dmc: No
The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB
      applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as
      compared to Standard of Care alone for the treatment of neuropathic and neurovascular
      diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile
      normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB
      will be applied on patients of the control group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of complete wound closure.
time frame: 20 weeks
measure: Time to achieve complete wound closure.
time frame: 20 weeks
measure: Percentage reduction in total ulcer surface area at each visit.
time frame: 20 weeks
measure: Incidence of complete wound healing
time frame: 10 weeks
measure: Number of ulcer recurrence observed 12 weeks after wound healing.
time frame: 32 weeks
measure: Treatment emergent adverse events.
time frame: 52 weeks
arm group label: BioChaperone PDGF-BB
arm group type: Experimental
description: BioChaperone PDGF-BB administered every other day at the dose of 4µg/cm² for 20 weeks or until wound closure, associated with Standard of Care
arm group label: Standard of Care
arm group type: Placebo Comparator
description: Normal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care
intervention type: Drug
intervention name: BioChaperone PDGF-BB
arm group label: BioChaperone PDGF-BB
intervention type: Other
intervention name: Standard of Care
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arun Bal, MD
role: Principal Investigator
affiliation: SL Raheja Hospital
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country: India
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
mesh term: Becaplermin