<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/NCT03296436</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00145403</org_study_id>
    <nct_id>NCT03296436</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds</brief_title>
  <official_title>A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3&#xD;
      who meet all of the inclusion and none exclusion criteria and give their informed consent,&#xD;
      will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those&#xD;
      patients will be seen in follow-up at weekly visits until the wound closes and epithelize,&#xD;
      achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or&#xD;
      at the end of the 16 treatment weeks will exit the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective investigator initiated trial will be conducted in diabetic patients with lower&#xD;
      extremity wounds managed with NEOX CORD 1K umbilical cord product supplied by Amniox (a&#xD;
      subsidiary of TissueTech, Inc.). The patient population will be comprised of Type 1 or Type 2&#xD;
      diabetics presenting to our hospital for the treatment of lower extremity wounds occurring on&#xD;
      the dorsal and plantar foot. The wounds will be treated in the Operating Room (OR) arena&#xD;
      including surgical debridement, resection of bone necrosis, biopsy, etc. to treat the&#xD;
      associated morbidity. These wounds are classified utilizing the University of Texas (UT)&#xD;
      Classification System as Grades: 2 (wounds penetrating to tendon or capsule) and 3 (wounds&#xD;
      penetrating to bone or joint) with Stages: A (no infection or ischemia), B (Infection&#xD;
      present), C (ischemia present) and D (Infection and ischemia present). This morbidity will&#xD;
      comprise of complex wounds that exhibit exposed muscle, tendon, bone and may include the&#xD;
      presence of treated osteomyelitis. This patient population oftentimes include diabetics with&#xD;
      lower extremity ischemia or end stage renal disease and their associated comorbidities. These&#xD;
      wounds are challenging in their care being they trend towards a poor prognosis including high&#xD;
      morbidity and mortality as well as high major limb amputation rates. Hence, this trial will&#xD;
      provide associated data to the efficacy of the above referenced material towards evaluating&#xD;
      its effectiveness in these wound types towards enhancing wound healing and subsequently&#xD;
      reducing amputation rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision - sponsor will be initiating a phase 3 mid-2019&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complete ulcer closure</measure>
    <time_frame>16 weeks</time_frame>
    <description>Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NEOX CORD 1K applications</measure>
    <time_frame>16 weeks</time_frame>
    <description>Total number of NEOX CORD 1K applications the subject received over the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ulcer surface area</measure>
    <time_frame>16 weeks</time_frame>
    <description>Percent change in the ulcer surface area (cm2) at each visit from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days to complete wound closure</measure>
    <time_frame>16 weeks</time_frame>
    <description>Time in number of days to complete wound closure over the 16-week treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean cost to closure</measure>
    <time_frame>16 weeks</time_frame>
    <description>Mean cost to closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrent ulcer-related complications</measure>
    <time_frame>16 weeks</time_frame>
    <description>• Proportion of subjects who experience recurrent ulcer-related complications (e.g., sepsis, osteomyelitis, limb amputation)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Diabetic Foot</condition>
  <condition>Diabetic Foot Infection</condition>
  <condition>Diabetic Foot Ulcer Mixed</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group that will be receiving the investigational product</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NEOX® CORD 1K®</intervention_name>
    <description>NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male/female age 18 or older&#xD;
&#xD;
          2. Type 1 or Type 2 diabetes mellitus&#xD;
&#xD;
          3. Signed informed consent&#xD;
&#xD;
          4. Wound present for minimum for four (4) weeks&#xD;
&#xD;
          5. Wound location foot to include the dorsal or plantar surface&#xD;
&#xD;
          6. Serum creatinine &lt; 3.0 mg/dL&#xD;
&#xD;
          7. HbA1c&lt; 12% taken prior to randomization&#xD;
&#xD;
          8. Patient presents with adequate circulation to the effected extremity, as demonstrated&#xD;
&#xD;
          9. by one of the following within sixty (60) days:&#xD;
&#xD;
         10. Ankle-Brachial Index (ABI) with results of &gt;0.6 and &lt;1.2&#xD;
&#xD;
         11. Doppler arterial waveforms which are triphasic or biphasic at ankle of affected lower&#xD;
             extremity&#xD;
&#xD;
         12. Wound is diabetic in origin with and area of &gt; 1 cm2 and &lt; 16 cm2 at time of screening&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
         13. Unwilling to follow the visit requirements and instructions outlined by the protocol&#xD;
&#xD;
         14. Currently receiving radiation therapy or chemotherapy&#xD;
&#xD;
         15. Non-vascular surgical site&#xD;
&#xD;
         16. The subject's wound can be addressed by primary closure&#xD;
&#xD;
         17. Received growth factors, living skin, dermal substitutes, silver-containing products,&#xD;
             amniotic membrane or umbilical cord products or other advanced biological therapies&#xD;
             for wounds within 30 days of screening&#xD;
&#xD;
         18. Pregnant or breast feeding&#xD;
&#xD;
         19. HbA1c: &gt; 12% within previous ninety (90) days&#xD;
&#xD;
         20. Serum creatinine level &gt; 3.0 mg/dL Taking medications that are considered immune&#xD;
             system modulators&#xD;
&#xD;
         21. Uncontrolled autoimmune surgical sites&#xD;
&#xD;
         22. Known or suspected local skin malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rondald Sherman, DPM, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot 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/NCT03296436
org study id: IRB00145403
nct id: NCT03296436
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3
      who meet all of the inclusion and none exclusion criteria and give their informed consent,
      will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those
      patients will be seen in follow-up at weekly visits until the wound closes and epithelize,
      achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or
      at the end of the 16 treatment weeks will exit the study.
A prospective investigator initiated trial will be conducted in diabetic patients with lower
      extremity wounds managed with NEOX CORD 1K umbilical cord product supplied by Amniox (a
      subsidiary of TissueTech, Inc.). The patient population will be comprised of Type 1 or Type 2
      diabetics presenting to our hospital for the treatment of lower extremity wounds occurring on
      the dorsal and plantar foot. The wounds will be treated in the Operating Room (OR) arena
      including surgical debridement, resection of bone necrosis, biopsy, etc. to treat the
      associated morbidity. These wounds are classified utilizing the University of Texas (UT)
      Classification System as Grades: 2 (wounds penetrating to tendon or capsule) and 3 (wounds
      penetrating to bone or joint) with Stages: A (no infection or ischemia), B (Infection
      present), C (ischemia present) and D (Infection and ischemia present). This morbidity will
      comprise of complex wounds that exhibit exposed muscle, tendon, bone and may include the
      presence of treated osteomyelitis. This patient population oftentimes include diabetics with
      lower extremity ischemia or end stage renal disease and their associated comorbidities. These
      wounds are challenging in their care being they trend towards a poor prognosis including high
      morbidity and mortality as well as high major limb amputation rates. Hence, this trial will
      provide associated data to the efficacy of the above referenced material towards evaluating
      its effectiveness in these wound types towards enhancing wound healing and subsequently
      reducing amputation rates.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete ulcer closure
time frame: 16 weeks
description: Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days.
measure: NEOX CORD 1K applications
time frame: 16 weeks
description: Total number of NEOX CORD 1K applications the subject received over the treatment period
measure: ulcer surface area
time frame: 16 weeks
description: Percent change in the ulcer surface area (cm2) at each visit from baseline
measure: number of days to complete wound closure
time frame: 16 weeks
description: Time in number of days to complete wound closure over the 16-week treatment period
measure: Mean cost to closure
time frame: 16 weeks
description: Mean cost to closure
measure: recurrent ulcer-related complications
time frame: 16 weeks
description: • Proportion of subjects who experience recurrent ulcer-related complications (e.g., sepsis, osteomyelitis, limb amputation)
arm group label: Treatment Group
arm group type: Experimental
description: Group that will be receiving the investigational product
intervention type: Biological
intervention name: NEOX® CORD 1K®
description: NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement.
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rondald Sherman, DPM, MBA
role: Principal Investigator
affiliation: Johns Hopkins University
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: Undecided