<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/NCT02209662</url>
  </required_header>
  <id_info>
    <org_study_id>Cyt201-01</org_study_id>
    <nct_id>NCT02209662</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers</brief_title>
  <official_title>A Multi-Center, Randomized Trial Comparing the Effectiveness of APIC-PRP to Control, When Added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cytonics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cytonics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with&#xD;
      physician-selected standard of care treatment such as debridement, hydrogel or saline&#xD;
      irrigation, primary dressing, and offloading will be randomized into one of two groups, the&#xD;
      Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce&#xD;
      growth factors that can help in wound healing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete wound closure within 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary outcome expected for this study is an increase in the proportion of DFUs that have exhibited complete closure within 12 weeks between the APIC-PRP + SoC groups and SoC alone groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in wound healing trajectory within 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The secondary outcome expected for this study is an improvement in wound healing trajectory of DFUs over the 12 weeks treatment period between the APIC-PRP + SoC groups and SoC alone groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in wound healing for the patient to return to function over the 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The secondary outcome expected for this study is an improvement in wound healing for the patient to return to function over the 12 weeks treatment period between the APIC-PRP + SoC groups and SoC alone groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">274</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>APIC-PRP and Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>APIC-PRP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, Saline plus standard of care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, Saline plus standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APIC-PRP</intervention_name>
    <description>APIC-PRP</description>
    <arm_group_label>APIC-PRP and Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo, Saline plus standard of care</intervention_name>
    <description>Placebo, Saline plus standard of care</description>
    <arm_group_label>Placebo, Saline plus standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior to the first clinical intervention, a signed Informed Consent Form (ICF) and&#xD;
             Data Consent Form (DCF) must be obtained from the subject or legal representative&#xD;
&#xD;
          -  Diagnosed with insulin-dependent or non-insulin-dependent diabetes (Type I or II,&#xD;
             respectively), requiring medical treatment as determined by the physician&#xD;
&#xD;
          -  Subjects will have only one diabetic foot ulcer on the target limb (referred to as the&#xD;
             Index Ulcer)&#xD;
&#xD;
          -  The Index Ulcer, classified using the University of Texas Wound Classification System&#xD;
             (Appendix 7), is located on the dorsal, plantar, medial, or lateral aspect of the foot&#xD;
             or heel (including all toe surfaces)&#xD;
&#xD;
          -  Debrided ulcer size between 1 cm2 and 4 cm2. See Appendix 3 for instructions on wound&#xD;
             area measurement&#xD;
&#xD;
          -  DFU with a duration ≥ 1 month at first visit&#xD;
&#xD;
          -  The target ulcer is free of clinical signs of infection, identified by inflammation&#xD;
             (redness, warmth, swelling, tenderness, or pain) or purulent exudates (Lipsky et al,&#xD;
             2012).&#xD;
&#xD;
          -  The patient meets Medicare/Medicaid eligibility requirements. Subject's ulcer extends&#xD;
             through the dermis and into subcutaneous tissue (granulation tissue may be present)&#xD;
             but without exposure of muscle, tendon, bone or joint capsule.&#xD;
&#xD;
          -  Post-debridement, subject's wound is free of necrotic debris and appears to be made up&#xD;
             of healthy vascularized tissue.&#xD;
&#xD;
          -  Demonstrated adequate offloading regimen.&#xD;
&#xD;
          -  Subject has adequate circulation to the study foot as evidenced by a Doppler measured&#xD;
             ankle-bronchial index (ABI) of ≥ 0.7 after 10 minutes of rest&#xD;
&#xD;
          -  Age &gt;18 years old at the time the informed consent is signed&#xD;
&#xD;
          -  Female subjects must have a negative urine pregnancy test prior to the first treatment&#xD;
&#xD;
          -  Subject must be willing to comply with the Protocol, which will be assessed by&#xD;
             enrolling clinician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has inadequate venous access the blood draw required for APIC-PRP&#xD;
             Administration. Subjects with PIC or IV access are preferred.&#xD;
&#xD;
          -  Hemoglobin of less than 12 g/dL&#xD;
&#xD;
          -  Inadequate amount of blood drawn to produce sufficient APIC-PRP. One complete APIC-PRP&#xD;
             preparation requires 114ml of blood drawn per APIC-PRP preparation.&#xD;
&#xD;
          -  Subject's ulcer has increased in size by &gt;50% during the run-in Screening period.&#xD;
&#xD;
          -  If the subject's ulcer healed by 25% or more during the run-in Screening period they&#xD;
             will be excluded.&#xD;
&#xD;
          -  Presence of another wound that is concurrently treated and might interfere with&#xD;
             treatment of the index wound by APIC-PRP (malignancy in nearby wound)&#xD;
&#xD;
          -  Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid,&#xD;
             collagen vascular disease, pressure, or arterial etiology)&#xD;
&#xD;
          -  The target ulcer demonstrates underlying osteomyelitis, defined as infection in the&#xD;
             bone, identified by Fever, chills, or pain in the infected bone. Any exposed bone will&#xD;
             be classified as osteomyelitis.&#xD;
&#xD;
          -  Subject has a history of bleeding disorder.&#xD;
&#xD;
          -  Any malignancy other than non-melanoma skin cancer requiring treatment with&#xD;
             immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less&#xD;
             than 30 days before enrolment.&#xD;
&#xD;
          -  Subject has gangrene present on any part of the affected limb. Subject's ulcer is over&#xD;
             a Charcot deformity of the mid-foot (&quot;Rocker-Bottom Foot&quot;) or over the tarsal&#xD;
             bones-talus, distal calcaneus, navicular, and cuboid.&#xD;
&#xD;
          -  Subject's ulcer has tunnels or sinus tracts that cannot be completely debrided.&#xD;
&#xD;
          -  Subject has severe malnutrition as evidenced by albumin &lt; 2.5 g/dL. A previous serum&#xD;
             albumin test that is &lt;6 weeks old is sufficient for this criteria.&#xD;
&#xD;
          -  Subject has Acquired Immunodeficiency Syndrome (AIDS), liver disease, aplastic anemia,&#xD;
             scleroderma, malignancy, cellulitis, suspected osteomyelitis or other evidence of&#xD;
             systemic infection, or is Human Immunodeficiency Virus (HIV)-positive.&#xD;
&#xD;
          -  Subject has any elective osseous procedures to the study foot within 30 days prior to&#xD;
             the Initial Visit.&#xD;
&#xD;
          -  Subject is on dialysis.&#xD;
&#xD;
          -  Subjects who are cognitively impaired and therefore can not give consent, and do not&#xD;
             have a healthcare proxy&#xD;
&#xD;
          -  Subjects who, in the opinion of the Investigator, represent poor medical,&#xD;
             psychological or psychiatric risks for whom therapy with an investigational product&#xD;
             would be unwise.&#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>Gaetano J Scuderi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cytonics Corporation</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>APIC-PRP</keyword>
  <keyword>Chronic Wounds</keyword>
  <keyword>Diabetic foot ulcer</keyword>
  <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>
  <!-- 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/NCT02209662
org study id: Cyt201-01
nct id: NCT02209662
lead sponsor: 
has dmc: No
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with
      physician-selected standard of care treatment such as debridement, hydrogel or saline
      irrigation, primary dressing, and offloading will be randomized into one of two groups, the
      Standard of Care (SoC) or APIC-PRP + SoC. APIC-PRP has high level of platelets that produce
      growth factors that can help in wound healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Complete wound closure within 12 weeks
time frame: 12 weeks
description: The primary outcome expected for this study is an increase in the proportion of DFUs that have exhibited complete closure within 12 weeks between the APIC-PRP + SoC groups and SoC alone groups.
measure: Improvement in wound healing trajectory within 12 weeks
time frame: 12 weeks
description: The secondary outcome expected for this study is an improvement in wound healing trajectory of DFUs over the 12 weeks treatment period between the APIC-PRP + SoC groups and SoC alone groups.
measure: Improvement in wound healing for the patient to return to function over the 12 weeks
time frame: 12 weeks
description: The secondary outcome expected for this study is an improvement in wound healing for the patient to return to function over the 12 weeks treatment period between the APIC-PRP + SoC groups and SoC alone groups.
arm group label: APIC-PRP and Standard of Care
arm group type: Experimental
description: APIC-PRP
arm group label: Placebo, Saline plus standard of care
arm group type: Placebo Comparator
description: Placebo, Saline plus standard of care
intervention type: Device
intervention name: APIC-PRP
description: APIC-PRP
arm group label: APIC-PRP and Standard of Care
intervention type: Other
intervention name: Placebo, Saline plus standard of care
description: Placebo, Saline plus standard of care
arm group label: Placebo, Saline plus standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gaetano J Scuderi, MD
role: Study Director
affiliation: Cytonics Corporation
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer