<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/NCT03276312</url>
  </required_header>
  <id_info>
    <org_study_id>ADF01</org_study_id>
    <nct_id>NCT03276312</nct_id>
  </id_info>
  <brief_title>Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot</brief_title>
  <official_title>Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Modena and Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Modena and Reggio Emilia</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 controlled monocentric study on 114 diabetic patients with the aim of&#xD;
      evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that&#xD;
      are candidates for a minor amputation in the foot. In particular, it will be evaluated&#xD;
      whether the lipofilling will be able to shorten the healing times and to reduce the number of&#xD;
      major amputations, with consequent positive impact on the quality of life. Patients will be&#xD;
      randomized to the treatment group with Lipogems® (local injection of autologous&#xD;
      micro-fractured adipose tissue) or to the control group, thus, treatment according to&#xD;
      standard clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective of this study is the evaluation of the time of the healing of the lesions&#xD;
      resulting from minor amputations (digital or forefoot) treated with Lipogems® technique.&#xD;
&#xD;
      Secondary objectives are: 1) assessment of the safety of the lipofilling; 2) evaluation of&#xD;
      the intensity of pain (VAS); 3) assessment of the skin tropism; 4) calculation of the relapse&#xD;
      rate (defined as the occurrence of local infections, dehiscence and suffering of skin flaps&#xD;
      that lead to a revision of the amputation stump or amputation at a higher level); 5)&#xD;
      evaluation of the time of hospitalization and quality of life (QoL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>
    <intervention_model_description>Randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healing time</measure>
    <time_frame>6 months</time_frame>
    <description>Healing time after the minor amputation intended as the complete healing of the amputation stump</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: All types of adverse events will be collected</measure>
    <time_frame>6 months</time_frame>
    <description>All types of adverse events will be collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of relapse</measure>
    <time_frame>6 months</time_frame>
    <description>Relapse is intended as revision of the amputation stump or amputation at a higher level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed using the Visual Analogue Scale (VAS) for pain</measure>
    <time_frame>6 months</time_frame>
    <description>Pain will be assessed using the VAS pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total time of hospitalization</measure>
    <time_frame>6 months</time_frame>
    <description>Hospitalization of the patient will be assessed counting the number of days in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total time of immobility</measure>
    <time_frame>6 months</time_frame>
    <description>Immobility of the patient will be assessed counting the number of bed rest days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life using the Short Form 36 (SF-36) questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lipogems - local injection of autologous micro-fragmented adipose tissue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine clinical practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lipogems</intervention_name>
    <description>Lipogems® is an innovative system that, starting from minimum quantities of autologous lipoaspirate, provides, with a minimal manipulation, a micro-fragmented and non-expanded adipose tissue product</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with diabetes (diabetes mellitus type 1 and type 2) of both sexes over the&#xD;
             age of 18 years.&#xD;
&#xD;
          2. Presence of irreversible gangrene digital or localized at forefoot (with X-ray of the&#xD;
             foot negative or positive for osteolytic lesions at phalanges and/or metatarsus).&#xD;
&#xD;
          3. Patients with vascular problems absent or resolved (evaluated with Eco Color Doppler&#xD;
             and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure&#xD;
             measured at the ankle and the systolic pressure in the arm, both measured in supine&#xD;
             position using wave continue Doppler. If assessable, it has to be greater than/equal&#xD;
             to 0.7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has&#xD;
             to be greater than/equal to 0.6) and/or by the determination of the transcutaneous&#xD;
             oxygen pressure (TcPO2 that needs to be equal to or greater than 30mmHg).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions&#xD;
&#xD;
          2. Patient under steroid therapy&#xD;
&#xD;
          3. Active vascular issues&#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>Roberto Silingardi, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baggiovara Hospital, Vascular Surgery department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Modena and Reggio Emilia</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Modena and Reggio Emilia</investigator_affiliation>
    <investigator_full_name>Giulia Trevisi Borsari</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Lipogems</keyword>
  <keyword>Adipose-derived Mesenchymal Stem Cells</keyword>
  <keyword>Lipofilling</keyword>
  <keyword>Diabetic foot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
  </condition_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/NCT03276312
org study id: ADF01
nct id: NCT03276312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled monocentric study on 114 diabetic patients with the aim of
      evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that
      are candidates for a minor amputation in the foot. In particular, it will be evaluated
      whether the lipofilling will be able to shorten the healing times and to reduce the number of
      major amputations, with consequent positive impact on the quality of life. Patients will be
      randomized to the treatment group with Lipogems® (local injection of autologous
      micro-fractured adipose tissue) or to the control group, thus, treatment according to
      standard clinical practice.
Primary objective of this study is the evaluation of the time of the healing of the lesions
      resulting from minor amputations (digital or forefoot) treated with Lipogems® technique.

      Secondary objectives are: 1) assessment of the safety of the lipofilling; 2) evaluation of
      the intensity of pain (VAS); 3) assessment of the skin tropism; 4) calculation of the relapse
      rate (defined as the occurrence of local infections, dehiscence and suffering of skin flaps
      that lead to a revision of the amputation stump or amputation at a higher level); 5)
      evaluation of the time of hospitalization and quality of life (QoL).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled study
primary purpose: Treatment
masking: None (Open Label)
measure: Healing time
time frame: 6 months
description: Healing time after the minor amputation intended as the complete healing of the amputation stump
measure: Safety: All types of adverse events will be collected
time frame: 6 months
description: All types of adverse events will be collected
measure: Incidence of relapse
time frame: 6 months
description: Relapse is intended as revision of the amputation stump or amputation at a higher level
measure: Pain assessed using the Visual Analogue Scale (VAS) for pain
time frame: 6 months
description: Pain will be assessed using the VAS pain scale
measure: Total time of hospitalization
time frame: 6 months
description: Hospitalization of the patient will be assessed counting the number of days in hospital
measure: Total time of immobility
time frame: 6 months
description: Immobility of the patient will be assessed counting the number of bed rest days
measure: Quality of Life using the Short Form 36 (SF-36) questionnaire
time frame: 6 months
description: Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire
arm group label: Intervention
arm group type: Experimental
description: Lipogems - local injection of autologous micro-fragmented adipose tissue
arm group label: Control
arm group type: No Intervention
description: Routine clinical practice
intervention type: Device
intervention name: Lipogems
description: Lipogems® is an innovative system that, starting from minimum quantities of autologous lipoaspirate, provides, with a minimal manipulation, a micro-fragmented and non-expanded adipose tissue product
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto Silingardi, Prof
role: Principal Investigator
affiliation: Baggiovara Hospital, Vascular Surgery department
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Modena and Reggio Emilia
investigator full name: Giulia Trevisi Borsari
investigator title: Dr
mesh term: Diabetic Foot
sharing ipd: No