<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/NCT04474808</url>
  </required_header>
  <id_info>
    <org_study_id>Foot cream trial</org_study_id>
    <nct_id>NCT04474808</nct_id>
  </id_info>
  <brief_title>Foot Cream for the Care of Dry and Cracked Skin</brief_title>
  <official_title>Investigation of the Effectiveness of a Foot Cream Containing L-arginine Compared to a Foot Cream Containing Urea for the Care of Dry and Cracked Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West German Center of Diabetes and Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bionatural GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>West German Center of Diabetes and Health</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>
      In healthy people, but especially in people with diabetes, dry and cracked skin areas on the&#xD;
      feet can occur. It is believed that the appearance of dry skin results from a deterioration&#xD;
      in the barrier function due to (neuro-) physiological or neuropathic changes in the skin. The&#xD;
      standard treatment for skin dryness mainly consists of appropriate care with moisturizing&#xD;
      cleaning and care products to protect and restore the barrier function of the skin. Care&#xD;
      products containing urea are often used here because urea reduces the feeling of dry and&#xD;
      cracked skin due to its moisturizing, keratoplastic, bacteriostatic, antifungal,&#xD;
      itch-relieving and proteolytic properties. However, urea-containing preparations can cause&#xD;
      painful skin irritation and burning pain on cracked, injured or extremely inflamed skin.&#xD;
      Comparable care effects with better tolerance were postulated for care creams enriched with&#xD;
      L-arginine. Therefore, a newly developed cream containing 4% L-arginine for the care of dry&#xD;
      and cracked skin should be tested in comparison to a conventional care cream containing 5%&#xD;
      urea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the participants are recruited during a routine visit to the outpatient clinic or the&#xD;
      study center of the West German Diabetes and Health Center (WDGZ), no visits to the study&#xD;
      center are necessary as part of the study.&#xD;
&#xD;
      recruitment&#xD;
&#xD;
        -  Check the inclusion and exclusion criteria&#xD;
&#xD;
        -  Clarification with written confirmation&#xD;
&#xD;
        -  Demographic data (including contact details)&#xD;
&#xD;
        -  Completing the foot care questionnaire (week 0)&#xD;
&#xD;
        -  Delivery of the two creams for the next six weeks&#xD;
&#xD;
        -  Handover questionnaires for week 2, 4 and 6 including prepaid envelopes&#xD;
&#xD;
      Study phase (6 weeks) Participants cream their feet with the study creams twice a day&#xD;
      (morning and evening) over a period of six weeks. Since there is no contact with medical&#xD;
      study staff during this time, undesirable study effects on the behavior of the participants&#xD;
      remain minimal.&#xD;
&#xD;
      The use of other creams or care products (except for cleaning) on the feet is not permitted&#xD;
      during the study phase.&#xD;
&#xD;
      Questionnaires Foot care questionnaires are completed after two, four, and six weeks and sent&#xD;
      to the study center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feet Care Feelings</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in the foot care score (according to the questionnaire) after 6 weeks to feel to what extent the skin is dry, rough, scaly, cracked, irritated or reddened, itchy, painful, smooth, tender, soft or horny.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>L-arginine-containing foot cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants apply one foot (randomized assignment) with the L-arginine-containing foot cream twice a day (morning and evening) over a period of six weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urea-containing foot cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants apply one foot (randomized assignment) with the Urea-containing foot cream twice a day (morning and evening) over a period of six weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>L-Arginin containing foot cream</intervention_name>
    <description>The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.</description>
    <arm_group_label>L-arginine-containing foot cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urea-containing foot cream</intervention_name>
    <description>The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.</description>
    <arm_group_label>Urea-containing foot cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Appearance of dry and cracked skin on the feet&#xD;
&#xD;
          -  Spoken and written knowledge of German&#xD;
&#xD;
          -  A written declaration of consent is available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric illness (e.g. dementia, schizophrenia), which affects the&#xD;
             understanding of what the clinical trial is about and the willingness to adhere to the&#xD;
             prescribed study procedure&#xD;
&#xD;
          -  The appearance of dry skin or itching as a result of an acute or chronic illness&#xD;
             (other than diabetes mellitus) or as a side effect of taking medication&#xD;
&#xD;
          -  Treatment with systemically or locally acting drugs, in which side effects of skin&#xD;
             changes or changes in the barrier function of the skin occur and can thus influence&#xD;
             the study results&#xD;
&#xD;
          -  Acute clinical symptoms of skin disease on the feet or legs&#xD;
&#xD;
          -  Lower limb amputation or acute diabetic foot syndrome&#xD;
&#xD;
          -  deep wounds on the feet or legs (Wagner stage 2 to 5)&#xD;
&#xD;
          -  Lack of mobility to be able to carry out daily skin care&#xD;
&#xD;
          -  Known allergy or intolerance to individual ingredients of the foot care products used&#xD;
             in the study&#xD;
&#xD;
          -  Restricted legal capacity or legal support&#xD;
&#xD;
          -  Participation in other clinical trials with - approved or non-approved - drugs or&#xD;
             medical devices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Martin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West German Centre of Diabetes and Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephan Martin, MD</last_name>
    <phone>+49(0)211-5660360</phone>
    <phone_ext>70</phone_ext>
    <email>stephan.martin@uni-duesseldorf.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kerstin Kempf, PhD</last_name>
    <phone>+49(0)211-5660360</phone>
    <phone_ext>16</phone_ext>
    <email>kerstin.kempf@wdgz.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>West German Centre of Diabetes and Health</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40591</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan Martin, MD</last_name>
      <phone>+49(0)211-5660360</phone>
      <phone_ext>70</phone_ext>
      <email>stephan.martin@uni-duesseldorf.de</email>
    </contact>
    <contact_backup>
      <last_name>Kerstin Kempf, PhD</last_name>
      <phone>+49(0)211-5660360</phone>
      <phone_ext>16</phone_ext>
      <email>kerstin.kempf@wdgz.de</email>
    </contact_backup>
    <investigator>
      <last_name>Stephan Martin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West German Center of Diabetes and Health</investigator_affiliation>
    <investigator_full_name>Stephan Martin</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <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/NCT04474808
org study id: Foot cream trial
nct id: NCT04474808
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In healthy people, but especially in people with diabetes, dry and cracked skin areas on the
      feet can occur. It is believed that the appearance of dry skin results from a deterioration
      in the barrier function due to (neuro-) physiological or neuropathic changes in the skin. The
      standard treatment for skin dryness mainly consists of appropriate care with moisturizing
      cleaning and care products to protect and restore the barrier function of the skin. Care
      products containing urea are often used here because urea reduces the feeling of dry and
      cracked skin due to its moisturizing, keratoplastic, bacteriostatic, antifungal,
      itch-relieving and proteolytic properties. However, urea-containing preparations can cause
      painful skin irritation and burning pain on cracked, injured or extremely inflamed skin.
      Comparable care effects with better tolerance were postulated for care creams enriched with
      L-arginine. Therefore, a newly developed cream containing 4% L-arginine for the care of dry
      and cracked skin should be tested in comparison to a conventional care cream containing 5%
      urea.
Since the participants are recruited during a routine visit to the outpatient clinic or the
      study center of the West German Diabetes and Health Center (WDGZ), no visits to the study
      center are necessary as part of the study.

      recruitment

        -  Check the inclusion and exclusion criteria

        -  Clarification with written confirmation

        -  Demographic data (including contact details)

        -  Completing the foot care questionnaire (week 0)

        -  Delivery of the two creams for the next six weeks

        -  Handover questionnaires for week 2, 4 and 6 including prepaid envelopes

      Study phase (6 weeks) Participants cream their feet with the study creams twice a day
      (morning and evening) over a period of six weeks. Since there is no contact with medical
      study staff during this time, undesirable study effects on the behavior of the participants
      remain minimal.

      The use of other creams or care products (except for cleaning) on the feet is not permitted
      during the study phase.

      Questionnaires Foot care questionnaires are completed after two, four, and six weeks and sent
      to the study center.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Feet Care Feelings
time frame: 6 weeks
description: Change in the foot care score (according to the questionnaire) after 6 weeks to feel to what extent the skin is dry, rough, scaly, cracked, irritated or reddened, itchy, painful, smooth, tender, soft or horny.
arm group label: L-arginine-containing foot cream
arm group type: Experimental
description: The participants apply one foot (randomized assignment) with the L-arginine-containing foot cream twice a day (morning and evening) over a period of six weeks.
arm group label: Urea-containing foot cream
arm group type: Active Comparator
description: The participants apply one foot (randomized assignment) with the Urea-containing foot cream twice a day (morning and evening) over a period of six weeks.
intervention type: Other
intervention name: L-Arginin containing foot cream
description: The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.
arm group label: L-arginine-containing foot cream
intervention type: Other
intervention name: Urea-containing foot cream
description: The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.
arm group label: Urea-containing foot cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephan Martin, MD
role: Principal Investigator
affiliation: West German Centre of Diabetes and Health
last name: Stephan Martin, MD
phone: +49(0)211-5660360
phone ext: 70
email: stephan.martin@uni-duesseldorf.de
last name: Kerstin Kempf, PhD
phone: +49(0)211-5660360
phone ext: 16
email: kerstin.kempf@wdgz.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: West German Center of Diabetes and Health
investigator full name: Stephan Martin
investigator title: Director
sharing ipd: No