<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/NCT02241811</url>
  </required_header>
  <id_info>
    <org_study_id>Boron wound</org_study_id>
    <nct_id>NCT02241811</nct_id>
  </id_info>
  <brief_title>Wound Treatment With 3% Sodium Pentaborate Pentahydrate</brief_title>
  <official_title>Deep Diabetic Foot Wound Treatment With Hydrogel Including 3% Sodium Pentaborate Pentahydrate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SB Istanbul Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SB Istanbul Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic foot wounds which is very difficult to treat are common especially in diabetic and&#xD;
      peripheral arterial or venous insufficiency patients. This research is aim to observe the&#xD;
      foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic foot wounds which is very difficult to treat are common especially in diabetic and&#xD;
      peripheral arterial or venous insufficiency patients. For these reason we prepared a hydrogel&#xD;
      formulations.&#xD;
&#xD;
      Gel preparation:&#xD;
&#xD;
      Hydrogel formulations were prepared by dispersing 1%(w/v) carbopol polymer (Carbopol&#xD;
      Ultrez-21, Lubrizol, USA) in distilled water. Neutralization buffer (1.6g of 1M sodium&#xD;
      hydroxide solution for 1L polymer-water suspension) was used for the gelation of the polymer.&#xD;
      Sodium pentaborate pentahydrate (3% w/v), F68 (2% w/v) and F127 (2% w/v) were mixed into the&#xD;
      blank hydrogel and stored at 4 °C until it completely dissolved (approximately 24 h). pH of&#xD;
      the hydrogel formulation was set to 6.5-7.0 using 1M sodium hydroxide. The hydrogel without&#xD;
      any active ingredient was used as negative control (vehicle).&#xD;
&#xD;
      For the first group after wound dressing we applied hydrogel with 3% Sodium pentaborate&#xD;
      pentahydrate, and for the control group after wound dressing we applied hydrogel without any&#xD;
      active ingredient everyday for two months. The same doctor observed and took photo of the&#xD;
      wounds every week in the outpatients clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound healing, Complication</measure>
    <time_frame>2 months</time_frame>
    <description>observation of wound healing and complications</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Wound Healing</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3% Sodium Pentaborate Pentahydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3% Sodium Pentaborate Pentahydrate</intervention_name>
    <description>For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.</description>
    <arm_group_label>3% Sodium Pentaborate Pentahydrate</arm_group_label>
    <other_name>3% Sodium Pentaborate Pentahydrate group, Control Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Hydrogel without 3% Sodium Pentaborate Pentahydrate</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diabetic Foot wounds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Child&#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_official>
    <last_name>Erhan Aysan, MD Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erhan Aysan, MD Prof.</last_name>
    <phone>+905322034879</phone>
    <email>erhanaysan@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bezmialem Vakif University</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erhan Aysan, MD Prof.</last_name>
      <phone>+905322034879</phone>
      <email>erhanaysan@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Erhan Aysan, MD Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SB Istanbul Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Erhan Aysan</investigator_full_name>
    <investigator_title>MD Prof.</investigator_title>
  </responsible_party>
  <keyword>Diabetic</keyword>
  <keyword>Foot</keyword>
  <keyword>Wound</keyword>
  <keyword>Sodium pentaborate pentahydrate</keyword>
  <keyword>Hydrogel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 21, 2021</submitted>
    <returned>January 31, 2022</returned>
  </pending_results>
  <!-- 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/NCT02241811
org study id: Boron wound
nct id: NCT02241811
lead sponsor: 
collaborator: 
has dmc: No
Chronic foot wounds which is very difficult to treat are common especially in diabetic and
      peripheral arterial or venous insufficiency patients. This research is aim to observe the
      foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.
Chronic foot wounds which is very difficult to treat are common especially in diabetic and
      peripheral arterial or venous insufficiency patients. For these reason we prepared a hydrogel
      formulations.

      Gel preparation:

      Hydrogel formulations were prepared by dispersing 1%(w/v) carbopol polymer (Carbopol
      Ultrez-21, Lubrizol, USA) in distilled water. Neutralization buffer (1.6g of 1M sodium
      hydroxide solution for 1L polymer-water suspension) was used for the gelation of the polymer.
      Sodium pentaborate pentahydrate (3% w/v), F68 (2% w/v) and F127 (2% w/v) were mixed into the
      blank hydrogel and stored at 4 °C until it completely dissolved (approximately 24 h). pH of
      the hydrogel formulation was set to 6.5-7.0 using 1M sodium hydroxide. The hydrogel without
      any active ingredient was used as negative control (vehicle).

      For the first group after wound dressing we applied hydrogel with 3% Sodium pentaborate
      pentahydrate, and for the control group after wound dressing we applied hydrogel without any
      active ingredient everyday for two months. The same doctor observed and took photo of the
      wounds every week in the outpatients clinic.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Wound healing, Complication
time frame: 2 months
description: observation of wound healing and complications
arm group label: Control
arm group type: Placebo Comparator
description: After wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
arm group label: 3% Sodium Pentaborate Pentahydrate
arm group type: Experimental
description: For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
intervention type: Drug
intervention name: 3% Sodium Pentaborate Pentahydrate
description: For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
arm group label: 3% Sodium Pentaborate Pentahydrate
other name: 3% Sodium Pentaborate Pentahydrate group, Control Group
intervention type: Drug
intervention name: Placebo
description: Hydrogel without 3% Sodium Pentaborate Pentahydrate
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Erhan Aysan, MD Prof.
role: Principal Investigator
affiliation: Bezmialem Vakif University
last name: Erhan Aysan, MD Prof.
phone: +905322034879
email: erhanaysan@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: SB Istanbul Education and Research Hospital
investigator full name: Erhan Aysan
investigator title: MD Prof.
mesh term: Wounds and Injuries
submitted: November 21, 2021
returned: January 31, 2022