<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/NCT04405050</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0268</org_study_id>
    <nct_id>NCT04405050</nct_id>
  </id_info>
  <brief_title>RCT to Compare Restrata and NPWT to Heal Complex DFUs</brief_title>
  <official_title>Randomized Clinical Trial to Compare Restrata and Negative Pressure Wound Therapy (NPWT) to Heal Complex Diabetic Foot Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Acera Surgical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of Restrata compared to Negative&#xD;
      Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening&#xD;
&#xD;
        1. Explain purpose and nature of the study and obtain signature on the informed consent&#xD;
           document.&#xD;
&#xD;
        2. Screen the subject against protocol inclusion and exclusion criteria, including all&#xD;
           pertinent tests, including pregnancy test if needed.&#xD;
&#xD;
      Baseline (may be done as same day as screening procedures)&#xD;
&#xD;
        1. Obtain general medical history and demographic information and social history&#xD;
&#xD;
        2. Complete a physical examination, body weight, height, and vital signs, including&#xD;
           measurement of resting heart rate, respiratory rate, and blood pressure while seated.&#xD;
&#xD;
        3. Select target study ulcer&#xD;
&#xD;
        4. Obtain complete history pertinent to DFU disease including duration of the target ulcer,&#xD;
           previous and current treatment.&#xD;
&#xD;
        5. Perform debridement and obtain tissue collection (3 tissue and 1 bone if applicable).&#xD;
&#xD;
        6. Perform standardized photography and measurement of the study wound (eKare or available&#xD;
           camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and&#xD;
           greatest depth (cm) using the inSight device (eKare, Fairfax, VA).&#xD;
&#xD;
        7. Perform hyperspectral imaging of dorsal and plantar aspects of the foot.&#xD;
&#xD;
        8. Perform neuropathy assessment (monofilament, VPT)&#xD;
&#xD;
        9. Skin perfusion pressure (Sensilase)&#xD;
&#xD;
       10. Collect all relevant concomitant medication (antibiotics, steroids, and diabetes&#xD;
           medications)&#xD;
&#xD;
       11. Complete questionnaires&#xD;
&#xD;
       12. Place Restrata and dress wound or apply NPWT therapy.&#xD;
&#xD;
       13. Submit subject stipend&#xD;
&#xD;
      Therapy/Treatment Phase&#xD;
&#xD;
      Study Visit 1-11:&#xD;
&#xD;
        1. Assess target ulcer (if wound has closed, document as such, skip to END OF STUDY VISIT&#xD;
           (EOS).&#xD;
&#xD;
        2. Document time on/off NPWT if applicable.&#xD;
&#xD;
        3. If Restrata is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth&#xD;
           (cm) using the inSight device - if the wound is deemed healed by the physician, skip to&#xD;
           EOS visit.&#xD;
&#xD;
        4. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is&#xD;
           active or healed.&#xD;
&#xD;
        5. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior&#xD;
           to dressing the wound&#xD;
&#xD;
        6. Collect all relevant concomitant medication.&#xD;
&#xD;
        7. If wound is not healed, redress the wound with Restrata dressing (if removed for&#xD;
           debridement) or NPWT.&#xD;
&#xD;
        8. Disburse subject stipend&#xD;
&#xD;
        9. Note: at week 3, if wound is not ready for surgical closure, remove Restrata and replace&#xD;
           with new piece of Restrata (per randomization schedule)&#xD;
&#xD;
       10. Assess for AE/SAEs and/or follow up on previous AE/SAEs.&#xD;
&#xD;
      Study Visit Closed&#xD;
&#xD;
        1. When a study wound has closed, we will perform the EOS evaluation.&#xD;
&#xD;
        2. If a wound has closed, the patient will enter the follow-up phase of the study.&#xD;
&#xD;
      Study Visit 12/EOS:&#xD;
&#xD;
        1. If the study wound closes prior to the 12-week study mark, subjects will perform EOS&#xD;
           visit at the time of wound closure.&#xD;
&#xD;
        2. Assess target ulcer.&#xD;
&#xD;
        3. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth&#xD;
           (cm) using the inSight device.&#xD;
&#xD;
        4. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is&#xD;
           active or healed.&#xD;
&#xD;
        5. If wound has not closed, redress the wound per physician-directed standard of care.&#xD;
&#xD;
        6. Perform EOS visit documentation&#xD;
&#xD;
        7. Complete questionnaires&#xD;
&#xD;
        8. Follow up on AE/SAEs that have not yet been resolved.&#xD;
&#xD;
      Study Visit Follow-up&#xD;
&#xD;
      1. If the wound heals during the treatment phase or if the wound is not healed after 12&#xD;
      weeks, data from their electronic medical record will be evaluated to identify healing, time&#xD;
      to heal, adverse events related to the wound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Project Never Initiated - no human subjects were enrolled and no data regarding humans was&#xD;
    collected or studied.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>Phase 4</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>This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare Restrata and NPWT in patients with complex diabetic foot ulcers.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound Closure</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary objective of this trial is to evaluate the incidence of wound closure. Closure is defined as complete epithelialization with no drainage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to wound healing</measure>
    <time_frame>12 weeks</time_frame>
    <description>Days to complete closure. Closure is defined as complete epithelialization with no drainage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in wound healing trajectories</measure>
    <time_frame>12 weeks</time_frame>
    <description>Defined as the change in wound area per week. Measured by wound measuring camera and PI observation/physical exam. Reported as mm^2 per day.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetic Wound</condition>
  <arm_group>
    <arm_group_label>Restrata</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with Restrata</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NPWT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with NPWT (Negative Pressure Wound Therapy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restrata</intervention_name>
    <description>Restrata® is a novel synthetic nanofabricated scaffold (Restrata Wound Matrix (RWM), Acera Surgical, St. Louis, Missouri) has been developed which is a sterile, single-use device intended for use in the local management of wounds. The RWM is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur (Figure 2). The RWM is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native ECM. As a viable wrap for surgical procedures, Restrata conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly.</description>
    <arm_group_label>Restrata</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Negative Pressure Wound Therapy (NPWT)</intervention_name>
    <description>Negative Pressure Wound Therapy (NPWT) has dramatically changed the care of complex foot wounds. Compared to standard wound care, patients with diabetic foot wounds that are treated with NPWT are 5.9 times more likely to heal and 4.4 times less likely to require amputation. NPWT involves the delivery of sub-atmospheric pressure through a vacuum pump connected to a specialized dressing to maintain a closed environment. NPWT increases perfusion to the wound, accelerates granulation tissue formation, reduces edema, and reduces bio-burden</description>
    <arm_group_label>NPWT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a diabetes mellitus&#xD;
&#xD;
          -  Men/women ≥21 years old&#xD;
&#xD;
          -  Post-operative foot or ankle wounds sized &lt; 15cm&#xD;
&#xD;
          -  ABI ≥0.5 or toe pressures &gt;30 mmHg&#xD;
&#xD;
          -  Wounds indicated for treatment with NPWT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Charcot arthropathy&#xD;
&#xD;
          -  Unable to use NPWT at home&#xD;
&#xD;
          -  Untreated bone or soft tissue infection&#xD;
&#xD;
          -  Is pregnant or plans to become pregnant&#xD;
&#xD;
          -  Is nursing or actively lactating&#xD;
&#xD;
          -  Developmental disability/significant psychological disorder that in the opinion of the&#xD;
             investigator could impair the subject's ability to provide informed consent,&#xD;
             participate in the study protocol or record study measures, including untreated&#xD;
             schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2&#xD;
             years.&#xD;
&#xD;
          -  Active alcohol or substance abuse in the opinion of the investigator that could impair&#xD;
             the subject's ability to provide informed consent, participate in the study protocol&#xD;
             or record study materials. Active alcohol (&gt; 14 drinks per week over the last 3&#xD;
             months) or substance abuse (current use of cocaine, heroin, or methamphetamines or if&#xD;
             drug or alcohol use will interfere with follow-up visits in foot clinic in the opinion&#xD;
             of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence Lavery, DPM MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Larry Lavery</investigator_full_name>
    <investigator_title>Professor and Director of Research</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT04405050
org study id: 2020-0268
nct id: NCT04405050
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to compare the efficacy of Restrata compared to Negative
      Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.
Screening

        1. Explain purpose and nature of the study and obtain signature on the informed consent
           document.

        2. Screen the subject against protocol inclusion and exclusion criteria, including all
           pertinent tests, including pregnancy test if needed.

      Baseline (may be done as same day as screening procedures)

        1. Obtain general medical history and demographic information and social history

        2. Complete a physical examination, body weight, height, and vital signs, including
           measurement of resting heart rate, respiratory rate, and blood pressure while seated.

        3. Select target study ulcer

        4. Obtain complete history pertinent to DFU disease including duration of the target ulcer,
           previous and current treatment.

        5. Perform debridement and obtain tissue collection (3 tissue and 1 bone if applicable).

        6. Perform standardized photography and measurement of the study wound (eKare or available
           camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and
           greatest depth (cm) using the inSight device (eKare, Fairfax, VA).

        7. Perform hyperspectral imaging of dorsal and plantar aspects of the foot.

        8. Perform neuropathy assessment (monofilament, VPT)

        9. Skin perfusion pressure (Sensilase)

       10. Collect all relevant concomitant medication (antibiotics, steroids, and diabetes
           medications)

       11. Complete questionnaires

       12. Place Restrata and dress wound or apply NPWT therapy.

       13. Submit subject stipend

      Therapy/Treatment Phase

      Study Visit 1-11:

        1. Assess target ulcer (if wound has closed, document as such, skip to END OF STUDY VISIT
           (EOS).

        2. Document time on/off NPWT if applicable.

        3. If Restrata is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth
           (cm) using the inSight device - if the wound is deemed healed by the physician, skip to
           EOS visit.

        4. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is
           active or healed.

        5. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior
           to dressing the wound

        6. Collect all relevant concomitant medication.

        7. If wound is not healed, redress the wound with Restrata dressing (if removed for
           debridement) or NPWT.

        8. Disburse subject stipend

        9. Note: at week 3, if wound is not ready for surgical closure, remove Restrata and replace
           with new piece of Restrata (per randomization schedule)

       10. Assess for AE/SAEs and/or follow up on previous AE/SAEs.

      Study Visit Closed

        1. When a study wound has closed, we will perform the EOS evaluation.

        2. If a wound has closed, the patient will enter the follow-up phase of the study.

      Study Visit 12/EOS:

        1. If the study wound closes prior to the 12-week study mark, subjects will perform EOS
           visit at the time of wound closure.

        2. Assess target ulcer.

        3. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth
           (cm) using the inSight device.

        4. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is
           active or healed.

        5. If wound has not closed, redress the wound per physician-directed standard of care.

        6. Perform EOS visit documentation

        7. Complete questionnaires

        8. Follow up on AE/SAEs that have not yet been resolved.

      Study Visit Follow-up

      1. If the wound heals during the treatment phase or if the wound is not healed after 12
      weeks, data from their electronic medical record will be evaluated to identify healing, time
      to heal, adverse events related to the wound.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare Restrata and NPWT in patients with complex diabetic foot ulcers.
primary purpose: Treatment
masking: None (Open Label)
measure: Wound Closure
time frame: 12 weeks
description: The primary objective of this trial is to evaluate the incidence of wound closure. Closure is defined as complete epithelialization with no drainage.
measure: Time to wound healing
time frame: 12 weeks
description: Days to complete closure. Closure is defined as complete epithelialization with no drainage.
measure: Differences in wound healing trajectories
time frame: 12 weeks
description: Defined as the change in wound area per week. Measured by wound measuring camera and PI observation/physical exam. Reported as mm^2 per day.
arm group label: Restrata
arm group type: Active Comparator
description: Treated with Restrata
arm group label: NPWT
arm group type: Active Comparator
description: Treated with NPWT (Negative Pressure Wound Therapy)
intervention type: Device
intervention name: Restrata
description: Restrata® is a novel synthetic nanofabricated scaffold (Restrata Wound Matrix (RWM), Acera Surgical, St. Louis, Missouri) has been developed which is a sterile, single-use device intended for use in the local management of wounds. The RWM is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur (Figure 2). The RWM is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native ECM. As a viable wrap for surgical procedures, Restrata conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly.
arm group label: Restrata
intervention type: Device
intervention name: Negative Pressure Wound Therapy (NPWT)
description: Negative Pressure Wound Therapy (NPWT) has dramatically changed the care of complex foot wounds. Compared to standard wound care, patients with diabetic foot wounds that are treated with NPWT are 5.9 times more likely to heal and 4.4 times less likely to require amputation. NPWT involves the delivery of sub-atmospheric pressure through a vacuum pump connected to a specialized dressing to maintain a closed environment. NPWT increases perfusion to the wound, accelerates granulation tissue formation, reduces edema, and reduces bio-burden
arm group label: NPWT
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Lawrence Lavery, DPM MPH
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Larry Lavery
investigator title: Professor and Director of Research
mesh term: Wounds and Injuries
sharing ipd: No