<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/NCT03781024</url>
  </required_header>
  <id_info>
    <org_study_id>PAS1467</org_study_id>
    <nct_id>NCT03781024</nct_id>
  </id_info>
  <brief_title>A Subjective Observational Study of Patients Using Medicated Footbath/Footwash Treatment in Podiatry Care</brief_title>
  <official_title>The Purpose of This Study is to Evaluate the Level of Relief Perceived by Patients Using Medicated Footbath/Footwash With or Without an Oral Medication for the Treatment of: Toenail Fungus Ingrown Toenails Cellulitis Athletes' Foot Pitted Keratolysis Diabetic Ulcers Open Infected Sores Abscesses Joint Infections Wound Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Data Collection Analysis Business Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Data Collection Analysis Business Management</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the level of relief perceived by patients using&#xD;
      medicated footbath/footwash with or without an oral medication for the treatment of podiatry&#xD;
      issues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Footwash/Footbath for treatment of; Toenail fungus Ingrown toenails Cellulitis Athletes' foot&#xD;
      Pitted Keratolysis Diabetic ulcers Open infected sores Abscesses Joint infections Wound care&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring effectiveness and quality of life from 0 to 10</measure>
    <time_frame>36 months</time_frame>
    <description>Collecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data. Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on footwash with or without oral medication and if it helped with the reduction or elimination of infections.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue scales</measure>
    <time_frame>36 months</time_frame>
    <description>By utilizing the Visual analogue scale from the patients' perspective will generate real world data</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Toenail Fungal Infection</condition>
  <condition>Cellulitis</condition>
  <condition>Pitted Keratolysis</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Abscess</condition>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Footwash</intervention_name>
    <description>footbath/footwash can help cleanse the wound, remove dead tissue, increase circulation and puts the wound in direct contact with medication to promote faster healing.</description>
    <other_name>Footbath</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        18-64 years of age male or female, no children, no incarcerated subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must be diagnosed with an ICD10 code indicative of Toenail Fungus, Ingrown&#xD;
        Toenail, Cellulitis, Athletes Foot, Pitted Keratolysis, Diabetic Ulcers, Open infected&#xD;
        sores, Abscesses, and Joint infections&#xD;
&#xD;
          -  Participants must be starting a new regimen of a medicated footwash/foothbath&#xD;
&#xD;
          -  Participants must be expecting to receive therapy for at least 12 weeks&#xD;
&#xD;
          -  Participants must be between 18 and 64 years of age&#xD;
&#xD;
          -  Participants must be able to provide sound verbal informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Participants must not be a beneficiary of government funded healthcare program (i.e.&#xD;
        Medicare, Medicaid, etc.)&#xD;
&#xD;
        • Participants must not have a diagnosis of cancer within the past 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>DCABM</name>
      <address>
        <city>Land O' Lakes</city>
        <state>Florida</state>
        <zip>33558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</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>Infections</mesh_term>
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Abscess</mesh_term>
    <mesh_term>Cellulitis</mesh_term>
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot 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/NCT03781024
org study id: PAS1467
nct id: NCT03781024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the level of relief perceived by patients using
      medicated footbath/footwash with or without an oral medication for the treatment of podiatry
      issues.
Footwash/Footbath for treatment of; Toenail fungus Ingrown toenails Cellulitis Athletes' foot
      Pitted Keratolysis Diabetic ulcers Open infected sores Abscesses Joint infections Wound care
observational model: Cohort
time perspective: Prospective
measure: Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring effectiveness and quality of life from 0 to 10
time frame: 36 months
description: Collecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data. Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on footwash with or without oral medication and if it helped with the reduction or elimination of infections.
measure: Visual Analogue scales
time frame: 36 months
description: By utilizing the Visual analogue scale from the patients' perspective will generate real world data
intervention type: Combination Product
intervention name: Footwash
description: footbath/footwash can help cleanse the wound, remove dead tissue, increase circulation and puts the wound in direct contact with medication to promote faster healing.
other name: Footbath
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Mycoses
mesh term: Abscess
mesh term: Cellulitis
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No