<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/NCT03790202</url>
  </required_header>
  <id_info>
    <org_study_id>VistaCare® OPEN PMCF</org_study_id>
    <nct_id>NCT03790202</nct_id>
  </id_info>
  <brief_title>VistaCare® in the Treatment of Wounds of the Lower Extremity</brief_title>
  <official_title>Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DTAMedical SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DTAMedical SAS</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of the safety and performance of the VistaCare® medical device in current medical&#xD;
      practice in the treatment of acute and chronic lower limb wounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an open-label, prospective, multicenter, post-CE mark (European Conformity&#xD;
      assessment indicating marketing approval in Europe) study to assess the safety and&#xD;
      performance of the VistaCare® device in the treatment of wounds. The duration of patient&#xD;
      follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following&#xD;
      initiation of treatment with the device.&#xD;
&#xD;
      Up to 30 patients will be recruited in the trial. Assessments will include clinical status,&#xD;
      wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in&#xD;
      a study sub-population, visual analogy scales to assess pain and comfort and adverse events&#xD;
      monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the global Performance of the VistaCare® device in standard medical practice</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of time under VistaCare treatment till secondary treatment decision</measure>
    <time_frame>up to 15 days</time_frame>
    <description>Assessment of the time in days till decision to wound coverage, graft, wound dressing, or no further treatment needed and patient discharge. Duration in days from VistaCare treatment initiation to decision-making will be tabulated for each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound surface calorimetric assessment of wound status</measure>
    <time_frame>30 days</time_frame>
    <description>Description of wound clinical status evolution through photography, wound measurement in mm2 and visual assessment of wound status. This measure is based on the surface in mm2 of the wound components on a standard photography, each wound potentially comprising 3 wound stages surfaces : necrotic (worst), granulation and epithelization (most favorable wound healing stage). Those stages are measured on each visit on a standardized photography of the wound and the wound stage evolution in time is assessed for each patient by an external reviewer. Wound staging for each patient will be analyzed in time throughout patient's participation and presented as graphs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events</measure>
    <time_frame>throughout 30 days</time_frame>
    <description>Safety assessment of the VistaCare® treatment through adverse events monitoring, with frequency of patients presenting with any adverse event and frequency of each adverse event type, namely non-serious unrelated or device-related event (respectively AE, ADE), serious unrelated event (SAE), serious device-related event (SADE), unanticipated device-related event (UADE), or device deficiency. Tabulation of frequencies in percentages of patient occurrence and number of events per patient will be provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TcPO2 assessment</measure>
    <time_frame>up to 30 days</time_frame>
    <description>In a sub-group of up to 10 patients, measure of the trans-cutaneous oxygen pressure (TcPO2) around the wound to assess status and potential correlation with wound status. This measure is expressed in mmHG and the correlation between this measure and the wound healing stage will be statistically assessed to indicate if wound healing may be correlated to the oxygen pressure measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assessments</measure>
    <time_frame>throughout 30 days</time_frame>
    <description>Patient visual analogy scale (VAS) assessments of pain and comfort. Those scales are each graduated from 0 (none) to 10 (maximum pain or discomfort). The evolution in times of such scores will be statistically assessed for each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>throughout 30 days</time_frame>
    <description>Assessment of the total duration of patient hospitalization in days.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Wound Heal</condition>
  <arm_group>
    <arm_group_label>single cohort of up to 30 patients</arm_group_label>
    <description>patients with acute or chronic lower limb wounds to be treated with the VistaCare® device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VistaCare®</intervention_name>
    <description>Controlled atmosphere wound healing device</description>
    <arm_group_label>single cohort of up to 30 patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients addressed to the hospital investigators, aged 18 and more,&#xD;
        suffering from acute or chronic lower extremity wounds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female consenting and able patients aged 18 or more affiliated to social&#xD;
             security&#xD;
&#xD;
          -  presenting with acute or chronic traumatic or surgical lower limb wounds (excluding&#xD;
             tumoral excision)&#xD;
&#xD;
          -  presenting with no intercurrent pathology which in the opinion of the investigator may&#xD;
             interfere with the capacity for wound healing&#xD;
&#xD;
          -  patients whose wound is compatible in terms of location with VistaCare treatment&#xD;
&#xD;
          -  patient whose wound has a minimal surface of 10 cm2&#xD;
&#xD;
          -  patient whose wound does not need surgical Peterson after inclusion (if needed should&#xD;
             be performed prior to inclusion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients pregnant, lactating, or of childbearing age and not using adequate&#xD;
             contraception (pregnancy test mandatory)&#xD;
&#xD;
          -  patients incapable of making an informed decision about participation&#xD;
&#xD;
          -  patients presenting a condition that interferes with adequate wound healing capacity&#xD;
             (uncontrolled diabetes, heavy smokers, auto-immune disease)&#xD;
&#xD;
          -  concurrent treatment or treatment within one month prior to inclusion with local or&#xD;
             systemic corticosteroids, immunosuppresseurs, chemotherapy or radiotherapy&#xD;
&#xD;
          -  wound location incompatible with VistaCare&#xD;
&#xD;
          -  general infection signs at the time of inclusion (fever, lymphangitis, pus ...)&#xD;
&#xD;
          -  patients presenting with important uncontrolled hemorrhage at the time of inclusion&#xD;
&#xD;
          -  patients previously recruited into this trial or any other trial within 1 month, or&#xD;
             currently in the exclusion timeframe of another trial&#xD;
&#xD;
          -  patients with a wound surface less than 10 cm2&#xD;
&#xD;
          -  patient with a would previously treated with hyperbaric chamber&#xD;
&#xD;
          -  legally incapacitated, under guardianship or psychiatric patients&#xD;
&#xD;
          -  emergency condition prohibiting adequate patient consent prior to inclusion&#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>Dominique Casanova, MD Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital de la Conception, Marseille, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Regis Legré, MD Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital de la Timone, Marseille, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-Edouard Magnan, MD Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital de la Timone, Marseille, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pascal Desgranges, MD Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Henri Mondor, Créteil, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Franck Duteille, MD Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Conception</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes Centre des Brûlés</name>
      <address>
        <city>Nantes</city>
        <zip>44093 Cedex 01</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.vistacare-medical.com</url>
    <description>Sponsor's internet site</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wound</keyword>
  <keyword>VistaCare</keyword>
  <keyword>wound healing</keyword>
  <keyword>controlled atmosphere</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 24, 2022</submitted>
    <returned>March 24, 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/NCT03790202
org study id: VistaCare® OPEN PMCF
nct id: NCT03790202
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Assessment of the safety and performance of the VistaCare® medical device in current medical
      practice in the treatment of acute and chronic lower limb wounds.
The study is an open-label, prospective, multicenter, post-CE mark (European Conformity
      assessment indicating marketing approval in Europe) study to assess the safety and
      performance of the VistaCare® device in the treatment of wounds. The duration of patient
      follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following
      initiation of treatment with the device.

      Up to 30 patients will be recruited in the trial. Assessments will include clinical status,
      wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in
      a study sub-population, visual analogy scales to assess pain and comfort and adverse events
      monitoring.
observational model: Cohort
time perspective: Prospective
measure: Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice
time frame: up to 30 days
description: Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial
measure: Assessment of the global Performance of the VistaCare® device in standard medical practice
time frame: up to 30 days
description: Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.
measure: Assessment of time under VistaCare treatment till secondary treatment decision
time frame: up to 15 days
description: Assessment of the time in days till decision to wound coverage, graft, wound dressing, or no further treatment needed and patient discharge. Duration in days from VistaCare treatment initiation to decision-making will be tabulated for each patient.
measure: Wound surface calorimetric assessment of wound status
time frame: 30 days
description: Description of wound clinical status evolution through photography, wound measurement in mm2 and visual assessment of wound status. This measure is based on the surface in mm2 of the wound components on a standard photography, each wound potentially comprising 3 wound stages surfaces : necrotic (worst), granulation and epithelization (most favorable wound healing stage). Those stages are measured on each visit on a standardized photography of the wound and the wound stage evolution in time is assessed for each patient by an external reviewer. Wound staging for each patient will be analyzed in time throughout patient's participation and presented as graphs.
measure: Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events
time frame: throughout 30 days
description: Safety assessment of the VistaCare® treatment through adverse events monitoring, with frequency of patients presenting with any adverse event and frequency of each adverse event type, namely non-serious unrelated or device-related event (respectively AE, ADE), serious unrelated event (SAE), serious device-related event (SADE), unanticipated device-related event (UADE), or device deficiency. Tabulation of frequencies in percentages of patient occurrence and number of events per patient will be provided.
measure: TcPO2 assessment
time frame: up to 30 days
description: In a sub-group of up to 10 patients, measure of the trans-cutaneous oxygen pressure (TcPO2) around the wound to assess status and potential correlation with wound status. This measure is expressed in mmHG and the correlation between this measure and the wound healing stage will be statistically assessed to indicate if wound healing may be correlated to the oxygen pressure measure.
measure: Quality of Life assessments
time frame: throughout 30 days
description: Patient visual analogy scale (VAS) assessments of pain and comfort. Those scales are each graduated from 0 (none) to 10 (maximum pain or discomfort). The evolution in times of such scores will be statistically assessed for each patient.
measure: Duration of hospitalization
time frame: throughout 30 days
description: Assessment of the total duration of patient hospitalization in days.
arm group label: single cohort of up to 30 patients
description: patients with acute or chronic lower limb wounds to be treated with the VistaCare® device
intervention type: Device
intervention name: VistaCare®
description: Controlled atmosphere wound healing device
arm group label: single cohort of up to 30 patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique Casanova, MD Pr
role: Principal Investigator
affiliation: Hôpital de la Conception, Marseille, France
last name: Regis Legré, MD Pr
role: Principal Investigator
affiliation: Hôpital de la Timone, Marseille, France
last name: Pierre-Edouard Magnan, MD Pr
role: Principal Investigator
affiliation: Hôpital de la Timone, Marseille, France
last name: Pascal Desgranges, MD Pr
role: Principal Investigator
affiliation: CHU Henri Mondor, Créteil, France
last name: Franck Duteille, MD Pr
role: Principal Investigator
affiliation: CHU Nantes, France
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
url: http://www.vistacare-medical.com
description: Sponsor's internet site
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No
submitted: January 24, 2022
returned: March 24, 2022