<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/NCT04450693</url>
  </required_header>
  <id_info>
    <org_study_id>TTAX01-CR005</org_study_id>
    <nct_id>NCT04450693</nct_id>
  </id_info>
  <brief_title>Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)</brief_title>
  <official_title>A Multicenter Phase 3 Confirmatory Trial of Biotherapy Using Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tissue Tech Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tissue Tech Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is hypothesized that application at 4-week or greater intervals of the human placental&#xD;
      umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer&#xD;
      (DFU) will, with concomitant management of infection, result in a higher rate of wounds&#xD;
      showing complete healing within 25 weeks of initiating therapy, compared with standard care&#xD;
      alone. This second confirmatory Phase 3 study examines a population of diabetic foot ulcer&#xD;
      patients having adequate perfusion, with or without neuropathy, and a high suspicion of&#xD;
      associated osteomyelitis in a complex, high grade wound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is designed as a confirmatory study of the benefits and risks of TTAX01 when used&#xD;
      in the treatment of Wagner Grades 3 and 4 DFU. Experience with the use of a cryopreserved&#xD;
      umbilical cord (UC) product in treating such wounds, both prior to this IND and under this&#xD;
      IND, has indicated that a frequency of application of no shorter than every 4 weeks is&#xD;
      associated with better than expected outcomes. Although treatment cannot be blinded, a&#xD;
      &quot;standard care only&quot; arm is included to control for the benefits of aggressive baseline&#xD;
      debridement combined with aggressive (6 weeks systemic) antibiotics. Current treatment&#xD;
      guidelines indicate that aggressive debridement plus 1-2 weeks of antibiotics, or, minor&#xD;
      debridement plus 6 weeks of antibiotics, would produce equivalent outcomes, although the&#xD;
      evidence is not strong. By utilizing both maximum debridement and maximum antimicrobial&#xD;
      therapy, the standard care described in this protocol may result in healing rates somewhat&#xD;
      superior to current standard practice.&#xD;
&#xD;
      The design of this second confirmatory study is matched to the design of the Phase 2 efficacy&#xD;
      study TTCRNE-1501, with the exception of extending the primary endpoint from a landmark&#xD;
      analysis at 16 to a &quot;wound survival&quot; analysis through 26 weeks, utilizing a proportional risk&#xD;
      analysis rather than a simple test of proportions. This design consideration is based on&#xD;
      analysis of previous studies (see Background section), and a desire to fold data from every&#xD;
      visit into the primary analysis, rather than generating an excessive number of secondary&#xD;
      endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2020</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
    <masking_description>Due to the nature of the test article, the trial is open label, with no blinding of the site staff. The determination of wound closure will be made by the Investigator based on visual and tactile assessment of the wound. To reduce bias in the ascertainment of closure, one independent blinded reviewer will review the image obtained from a wound measurement device in each case where the Investigator makes a determination of closure. Discordant opinions will be adjudicated by a second independent blinded reviewer who will examine multiple additional images taken at various angles to the wound surface.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Complete wound healing</measure>
    <time_frame>over 25 weeks</time_frame>
    <description>Time from baseline to initial observation of healing, where healing has been confirmed at two consecutive visits each two weeks apart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound durability</measure>
    <time_frame>by Week 26</time_frame>
    <description>Proportion of wounds that re-ulcerate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Limb preservation</measure>
    <time_frame>by Week 26</time_frame>
    <description>proportion of minor and major amputations following the initial procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported mobility</measure>
    <time_frame>Baseline to End of Study (approximately 26 weeks)</time_frame>
    <description>compare total score on PROMIS Health Organization Neuro-QoL 'lower extremity function'; scale from 1-5; higher scores indicate better self-reported health</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Diabetic Foot Infection</condition>
  <condition>Non-healing Wound</condition>
  <condition>Non-healing Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>TTAX01</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TTAX01 plus standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard care alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TTAX01</intervention_name>
    <description>TTAX01 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. TTAX01 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. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of lactated Ringer's/glycerol (1:1).</description>
    <arm_group_label>TTAX01</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Standard care is defined in this protocol to consist of the following:&#xD;
Debridement;&#xD;
Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited;&#xD;
Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate;&#xD;
A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin;&#xD;
Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and,&#xD;
Appropriate use of systemic antibiotics.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>TTAX01</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject has signed the informed consent form&#xD;
&#xD;
          -  The subject is male or female, at least 18 years of age inclusive at the date of&#xD;
             Screening&#xD;
&#xD;
          -  The subject has confirmed diagnosis of Type I or Type II diabetes&#xD;
&#xD;
          -  The subject's index ulcer is located on the plantar surface, inter digital, heel,&#xD;
             lateral or medial surface of the foot&#xD;
&#xD;
          -  The subject has an index ulcer with visible margins having an area ≤ 12.0 cm2 when&#xD;
             measured by the electronic measuring device at Screening&#xD;
&#xD;
          -  The subject's index ulcer extends beyond the dermis, into subcutaneous tissue with&#xD;
             evidence of exposed bone, tendon, muscle and/or joint capsule&#xD;
&#xD;
          -  The subject presents with history, signs or symptoms leading to a clinical suspicion&#xD;
             of osteomyelitis in the opinion of the Investigator supported by positive Probe to&#xD;
             Bone (PTB) and any of the following: radiographic (X-ray, Magnetic Resonance Imaging&#xD;
             (MRI), or bone scan) or evidence of bone necrosis&#xD;
&#xD;
          -  The subject has an Ankle-Brachial Index ≥ 0.7 to ≤ 1.3 or TcPO2 ≥ 40 mmHg on the&#xD;
             dorsum of the affected foot, or Great Toe Pressure ≥ 50 mmHg&#xD;
&#xD;
          -  The subject is under the care of a physician for the management of Diabetes Mellitus&#xD;
&#xD;
          -  The subject is willing to return for all mandatory visits as defined in the protocol&#xD;
&#xD;
          -  The subject is willing to follow the instructions of the trial Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject's index ulcer is primarily located on the dorsal surface of the foot&#xD;
&#xD;
          -  The subject's index ulcer can be addressed by primary closure through the completion&#xD;
             of the initial or staged surgical procedure&#xD;
&#xD;
          -  The subject has a contralateral major amputation of the lower extremity&#xD;
&#xD;
          -  The subject has a glycated hemoglobin A1c (HbA1c) level of &gt; 12% †&#xD;
&#xD;
          -  The subject has been on oral steroid use of &gt; 7.5 mg daily for greater than seven (7)&#xD;
             consecutive days in 30 days before Screening&#xD;
&#xD;
          -  The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven&#xD;
             consecutive days in the period of 30 days before Screening&#xD;
&#xD;
          -  The subject is currently taking the type 2 diabetes medicine canagliflozin (Invokana™,&#xD;
             Invokamet™, Invokamet XR™)&#xD;
&#xD;
          -  The subject has malignancy or a history of cancer, other than non-melanoma skin&#xD;
             cancer, in five years before Screening&#xD;
&#xD;
          -  The subject is pregnant&#xD;
&#xD;
          -  The subject is a nursing mother&#xD;
&#xD;
          -  The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy&#xD;
             or use an appropriate form of birth control (adequate birth control methods are&#xD;
             defined as: topical, oral, implantable, or injectable contraceptives; spermicide in&#xD;
             conjunction with a barrier such as a condom or diaphragm; intrauterine contraceptive&#xD;
             device; or surgical sterilization of partner).&#xD;
&#xD;
          -  The subject is unable to sustain off-loading as defined by the protocol&#xD;
&#xD;
          -  The subject has an allergy to primary or secondary dressing materials used in this&#xD;
             trial&#xD;
&#xD;
          -  The subject has an allergy to glycerol&#xD;
&#xD;
          -  The subject's index ulcer is over an acute Charcot deformity&#xD;
&#xD;
          -  The subject has had previous use of NEOX®, CLARIX®, or TTAX01 applied to the index&#xD;
             ulcer&#xD;
&#xD;
          -  Per Investigator's discretion the subject is not appropriate for inclusion in the&#xD;
             trial, e.g., undergoing surgical treatments listed in the protocol or the subject&#xD;
             currently has sepsis, i.e., life-threatening organ dysfunction caused by a&#xD;
             dysregulated host response to infection&#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>Herbert Slade, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathleen Ripp</last_name>
    <phone>786-753-2037</phone>
    <email>kripp@biotissue.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stanley Harris</last_name>
    <phone>678-722-9923</phone>
    <email>sharris@biotissue.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>LakeView Clinical Research</name>
      <address>
        <city>Guntersville</city>
        <state>Alabama</state>
        <zip>35976</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manny Ruiz</last_name>
      <email>mr476@arizona.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>NorthBay Healthcare</name>
      <address>
        <city>Fairfield</city>
        <state>California</state>
        <zip>94534</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>VA Northern California Health Care System</name>
      <address>
        <city>Mather</city>
        <state>California</state>
        <zip>95655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pallas Lim</last_name>
      <email>Pallas.Lim@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CureCentric</name>
      <address>
        <city>Palmdale</city>
        <state>California</state>
        <zip>93551</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brenda Velador</last_name>
      <email>bvelador@curecentric.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>PIH Health</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristine Bradbury</last_name>
      <email>Kristine.Bradbury@PIHHealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Midland Florida Clinical Research Center</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacey-Ann Villaruel</last_name>
      <email>staceyann.mfcrc@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Delray Physician Care Center</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Gateway Clinical Trials, LLC</name>
      <address>
        <city>O'Fallon</city>
        <state>Illinois</state>
        <zip>62269</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristin Reinitz</last_name>
      <email>kristinreinitz@podiatry1st.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Reno Orthopedic Clinic</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janice Ta</last_name>
      <email>janicet@renoortho.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Curalta Foot and Ankle</name>
      <address>
        <city>Westwood</city>
        <state>New Jersey</state>
        <zip>07675</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin Carbone</last_name>
      <email>kcarbone@curalta.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northwell Health Comprehensive Wound Healing Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Cutting Edge Research, LLC</name>
      <address>
        <city>Circleville</city>
        <state>Ohio</state>
        <zip>43113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Liden</last_name>
      <email>researchbase969@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UPMC Center for Innovation in Restorative Medicine</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Biolife Genetics Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Bio-X-Cell Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>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/NCT04450693
org study id: TTAX01-CR005
nct id: NCT04450693
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
It is hypothesized that application at 4-week or greater intervals of the human placental
      umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer
      (DFU) will, with concomitant management of infection, result in a higher rate of wounds
      showing complete healing within 25 weeks of initiating therapy, compared with standard care
      alone. This second confirmatory Phase 3 study examines a population of diabetic foot ulcer
      patients having adequate perfusion, with or without neuropathy, and a high suspicion of
      associated osteomyelitis in a complex, high grade wound.
This trial is designed as a confirmatory study of the benefits and risks of TTAX01 when used
      in the treatment of Wagner Grades 3 and 4 DFU. Experience with the use of a cryopreserved
      umbilical cord (UC) product in treating such wounds, both prior to this IND and under this
      IND, has indicated that a frequency of application of no shorter than every 4 weeks is
      associated with better than expected outcomes. Although treatment cannot be blinded, a
      "standard care only" arm is included to control for the benefits of aggressive baseline
      debridement combined with aggressive (6 weeks systemic) antibiotics. Current treatment
      guidelines indicate that aggressive debridement plus 1-2 weeks of antibiotics, or, minor
      debridement plus 6 weeks of antibiotics, would produce equivalent outcomes, although the
      evidence is not strong. By utilizing both maximum debridement and maximum antimicrobial
      therapy, the standard care described in this protocol may result in healing rates somewhat
      superior to current standard practice.

      The design of this second confirmatory study is matched to the design of the Phase 2 efficacy
      study TTCRNE-1501, with the exception of extending the primary endpoint from a landmark
      analysis at 16 to a "wound survival" analysis through 26 weeks, utilizing a proportional risk
      analysis rather than a simple test of proportions. This design consideration is based on
      analysis of previous studies (see Background section), and a desire to fold data from every
      visit into the primary analysis, rather than generating an excessive number of secondary
      endpoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Due to the nature of the test article, the trial is open label, with no blinding of the site staff. The determination of wound closure will be made by the Investigator based on visual and tactile assessment of the wound. To reduce bias in the ascertainment of closure, one independent blinded reviewer will review the image obtained from a wound measurement device in each case where the Investigator makes a determination of closure. Discordant opinions will be adjudicated by a second independent blinded reviewer who will examine multiple additional images taken at various angles to the wound surface.
measure: Complete wound healing
time frame: over 25 weeks
description: Time from baseline to initial observation of healing, where healing has been confirmed at two consecutive visits each two weeks apart.
measure: Wound durability
time frame: by Week 26
description: Proportion of wounds that re-ulcerate
measure: Limb preservation
time frame: by Week 26
description: proportion of minor and major amputations following the initial procedure
measure: Patient-reported mobility
time frame: Baseline to End of Study (approximately 26 weeks)
description: compare total score on PROMIS Health Organization Neuro-QoL 'lower extremity function'; scale from 1-5; higher scores indicate better self-reported health
arm group label: TTAX01
arm group type: Experimental
description: TTAX01 plus standard of care
arm group label: Control
arm group type: Other
description: Standard care alone
intervention type: Biological
intervention name: TTAX01
description: TTAX01 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. TTAX01 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. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of lactated Ringer's/glycerol (1:1).
arm group label: TTAX01
intervention type: Other
intervention name: Standard care
description: Standard care is defined in this protocol to consist of the following:
Debridement;
Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited;
Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate;
A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin;
Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and,
Appropriate use of systemic antibiotics.
arm group label: Control
arm group label: TTAX01
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Herbert Slade, MD
role: Study Chair
affiliation: Chief Medical Officer
last name: Kathleen Ripp
phone: 786-753-2037
email: kripp@biotissue.com
last name: Stanley Harris
phone: 678-722-9923
email: sharris@biotissue.com
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Terminated
facility: 
status: Withdrawn
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No