<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/NCT02987101</url>
  </required_header>
  <id_info>
    <org_study_id>S-201502002</org_study_id>
    <nct_id>NCT02987101</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction</brief_title>
  <official_title>Treatment of Chronic Leg Ulcers With Autologous Stromal Vascular Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic leg ulcers are associated with decreased quality of life and an increased mortality.&#xD;
      In many cases these ulcers are treated conservatively and the healing time can be several&#xD;
      months. In this open randomized clinical trial we will examine if we can accelerate wound&#xD;
      healing when using autologous stromal vascular fraction as an adjunct to standard wound care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic leg ulcers are associated with decreased quality of life and an increased mortality.&#xD;
      In many cases these ulcers are treated conservatively and the healing time can be several&#xD;
      months. In this open randomized clinical trial we will examine if we can accelerate wound&#xD;
      healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound&#xD;
      care.&#xD;
&#xD;
      The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and&#xD;
      these are randomized in two groups of which one receives standard wound care only and the&#xD;
      other group receives autologous stromal vascular fraction treatment in addition to standard&#xD;
      wound care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in wound size</measure>
    <time_frame>6 months</time_frame>
    <description>Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distal blood pressure measurement</measure>
    <time_frame>6 months</time_frame>
    <description>Change in distal blood pressure measurement before and 6 months after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcutaneous oxygen tension</measure>
    <time_frame>6 months</time_frame>
    <description>Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Monitoring of any side effects or complications related to intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Leg Ulcer</condition>
  <arm_group>
    <arm_group_label>Autologous SVF + Standard of care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>local injection around and under wound with autologous stromal vascular fraction.&#xD;
Standard wound care is given independent of this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard wound care is given independent of this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liposuction</intervention_name>
    <description>Adipose tissue is harvested by liposuction from either abdomen or thighs.</description>
    <arm_group_label>Autologous SVF + Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard wound care</intervention_name>
    <description>Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.</description>
    <arm_group_label>Autologous SVF + Standard of care</arm_group_label>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adipose-Derived Regenerative Cells</intervention_name>
    <description>Cells isolated from adipose-derived tissue will be injected locally around and under the wound.</description>
    <arm_group_label>Autologous SVF + Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Arteriovenous chronic leg ulcer&#xD;
&#xD;
          -  Present beyond 4 months&#xD;
&#xD;
          -  Conservative treatment not leading to progress&#xD;
&#xD;
          -  Wound size between 2-30cm2&#xD;
&#xD;
          -  ankle-brachial index (ABI) ( 50-90% and/or toe pressure 50-70% and where ankle&#xD;
             pressure &gt; 60 mmHg or toe pressure &gt; 40 mmHg&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled wound infection&#xD;
&#xD;
          -  Osteomyelitis&#xD;
&#xD;
          -  Hemoglobin &lt;6.0mmol/L&#xD;
&#xD;
          -  HbA1c &gt;80mmol/mol&#xD;
&#xD;
          -  Underlying malignancy&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  Renal insufficiency requiring dialysis&#xD;
&#xD;
          -  Charcot foot&#xD;
&#xD;
          -  Underlying malignancy&#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>Jens A Sørensen, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Dept. Plastic Surgery, OUH, Consultant, Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Navid M Toyserkani, MD</last_name>
    <phone>+4550383833</phone>
    <email>navid.m.toyserkani@rsyd.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Navid M Toyserkani, MD</last_name>
      <phone>+4550383833</phone>
      <email>navid.m.toyserkani@rsyd.dk</email>
    </contact>
    <investigator>
      <last_name>Navid M Toyserkani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Navid Toyserkani</investigator_full_name>
    <investigator_title>Resident, PhD fellow, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Ulcer</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/NCT02987101
org study id: S-201502002
nct id: NCT02987101
lead sponsor: 
has dmc: Yes
Chronic leg ulcers are associated with decreased quality of life and an increased mortality.
      In many cases these ulcers are treated conservatively and the healing time can be several
      months. In this open randomized clinical trial we will examine if we can accelerate wound
      healing when using autologous stromal vascular fraction as an adjunct to standard wound care.
Chronic leg ulcers are associated with decreased quality of life and an increased mortality.
      In many cases these ulcers are treated conservatively and the healing time can be several
      months. In this open randomized clinical trial we will examine if we can accelerate wound
      healing when using autologous stromal vascular fraction (SVF) as an adjunct to standard wound
      care.

      The plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and
      these are randomized in two groups of which one receives standard wound care only and the
      other group receives autologous stromal vascular fraction treatment in addition to standard
      wound care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in wound size
time frame: 6 months
description: Photography is taken every 2 weeks until complete wound healing. Final follow-up date regardless of complete wound healing or not is 6 months.
measure: Distal blood pressure measurement
time frame: 6 months
description: Change in distal blood pressure measurement before and 6 months after treatment
measure: Transcutaneous oxygen tension
time frame: 6 months
description: Change in transcutaneous oxygen tension around the wound before and 6 months after treatment.
measure: Treatment-related adverse events
time frame: 6 months
description: Monitoring of any side effects or complications related to intervention
arm group label: Autologous SVF + Standard of care
arm group type: Experimental
description: local injection around and under wound with autologous stromal vascular fraction.
Standard wound care is given independent of this study.
arm group label: Standard of care
arm group type: Other
description: Standard wound care is given independent of this study.
intervention type: Procedure
intervention name: Liposuction
description: Adipose tissue is harvested by liposuction from either abdomen or thighs.
arm group label: Autologous SVF + Standard of care
intervention type: Other
intervention name: Standard wound care
description: Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
arm group label: Autologous SVF + Standard of care
arm group label: Standard of care
intervention type: Drug
intervention name: Adipose-Derived Regenerative Cells
description: Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
arm group label: Autologous SVF + Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens A Sørensen, MD PhD
role: Study Chair
affiliation: Dept. Plastic Surgery, OUH, Consultant, Professor
last name: Navid M Toyserkani, MD
phone: +4550383833
email: navid.m.toyserkani@rsyd.dk
facility: 
status: Recruiting
contact: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Navid Toyserkani
investigator title: Resident, PhD fellow, MD
mesh term: Leg Ulcer
mesh term: Ulcer
sharing ipd: Undecided