<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/NCT03813927</url>
  </required_header>
  <id_info>
    <org_study_id>REG-48-2015</org_study_id>
    <nct_id>NCT03813927</nct_id>
  </id_info>
  <brief_title>Vitamin D Treatment of Diabetic Patients With Foot Ulcers</brief_title>
  <official_title>Systemic Vitamin D Treatment of Diabetic Patients With Foot Ulcers: a Clinical Controlled Investigation of the Effect on Healing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study, is to determine whether daily supplements of vitamin D improves&#xD;
      wound healing in diabetic patients with chronic foot ulcers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project title&#xD;
&#xD;
      &quot;Treatment with oral vitamin D in diabetic patients with chronic foot ulcers on the lower&#xD;
      limb; a clinical controlled study of the effect on wound healing&quot;.&#xD;
&#xD;
      Abstract&#xD;
&#xD;
      Aims and objectives&#xD;
&#xD;
      The purpose of this study is to determine whether daily supplements of vitamin D improves&#xD;
      wound healing in diabetic patients with chronic foot ulcers.&#xD;
&#xD;
      Background&#xD;
&#xD;
      Lifetime risk of developing chronic lower extremity ulcers summarized in type I and type II&#xD;
      diabetics is about 25% and the prevalence is approximately 7%. There is often a long term&#xD;
      resource consuming disorder where 47% of the diabetic leg and foot ulcers effectively can be&#xD;
      treated within 12 months.&#xD;
&#xD;
      In Denmark in 2011 there were more than 300,000 diagnosed type I and type II diabetics, and&#xD;
      estimated about 200,000 undiagnosed type II diabetics. Therefore, approximately 35,000&#xD;
      diabetics each year are treated for chronic leg or foot ulcers in the Danish health sector.&#xD;
      The treatment of these chronic wounds are associated with significant costs, as well as&#xD;
      emotional, physical and financial.&#xD;
&#xD;
      Vitamin D deficiency is a widespread problem, and it is estimated that worldwide there is 1&#xD;
      billion people suffering from vitamin D deficiency. A Danish study from 2012 showed vitamin D&#xD;
      deficiency in 52% of adults aged 30 60 years. Vitamin D deficiency is more common in&#xD;
      diabetics with chronic foot or leg ulcers, when compared with non diabetics and diabetics&#xD;
      without ulcers.&#xD;
&#xD;
      Methods and materials&#xD;
&#xD;
      48 diabetic patients with chronic foot ulcers will be included in the study. The patients&#xD;
      will be recruited from the outpatient clinic, department of orthopaedic surgery at Zealand&#xD;
      University Hospital, Denmark. The patients will randomly be divided into two groups,&#xD;
      respectively treated with vitamin D or placebo.&#xD;
&#xD;
      Expected outcome and perspectives&#xD;
&#xD;
      The investigators expect that this study will show that supplementation with oral vitamin D,&#xD;
      will result in a significant effect on wound treatment and healing for a large group of&#xD;
      diabetic patients with chronic foot ulcers. This will contribute to a changed procedure in&#xD;
      this specific group of patients, leading to measurement of vitamin D status and&#xD;
      supplementation with vitamin D if needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">July 3, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound healing</measure>
    <time_frame>48 weeks or wound healing.</time_frame>
    <description>Wound healing, measured in square cm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin D blod level status</measure>
    <time_frame>48 weeks or wound healing.</time_frame>
    <description>Vitamin D blod level status in intervention Group after supplementation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Diabetic Foot Ulcers</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>supplementation with tablet 170 μg Vitamin D each day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, tablet with 20 μg Vitamin D each day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Supplementation with tablet 170 μg Vitamin each day.</description>
    <arm_group_label>Vitamin D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo with tablet 20 μg Vitamin each day.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Diagnosed diabetes.&#xD;
&#xD;
          3. Foot ulcers more than 6 weeks.&#xD;
&#xD;
          4. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Granulomatous diseases such as tuberculosis, sarcoidosis and silicosis&#xD;
&#xD;
          3. Hypercalcemia&#xD;
&#xD;
          4. Supplementation of vitamin D &gt; 20 μg a day&#xD;
&#xD;
          5. Renal disease&#xD;
&#xD;
          6. Liver disease&#xD;
&#xD;
          7. Osteomyelitis&#xD;
&#xD;
          8. Skin cancer.&#xD;
&#xD;
          9. Epilepsy.&#xD;
&#xD;
         10. High blod pressure (&gt; 150/100 mmHg).&#xD;
&#xD;
         11. Indication for surgical revision.&#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>Peter Max Halschou-Jensen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Zeeland University Hospital, Denmark</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 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>Vitamin D Deficiency</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_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/NCT03813927
org study id: REG-48-2015
nct id: NCT03813927
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study, is to determine whether daily supplements of vitamin D improves
      wound healing in diabetic patients with chronic foot ulcers.
Project title

      "Treatment with oral vitamin D in diabetic patients with chronic foot ulcers on the lower
      limb; a clinical controlled study of the effect on wound healing".

      Abstract

      Aims and objectives

      The purpose of this study is to determine whether daily supplements of vitamin D improves
      wound healing in diabetic patients with chronic foot ulcers.

      Background

      Lifetime risk of developing chronic lower extremity ulcers summarized in type I and type II
      diabetics is about 25% and the prevalence is approximately 7%. There is often a long term
      resource consuming disorder where 47% of the diabetic leg and foot ulcers effectively can be
      treated within 12 months.

      In Denmark in 2011 there were more than 300,000 diagnosed type I and type II diabetics, and
      estimated about 200,000 undiagnosed type II diabetics. Therefore, approximately 35,000
      diabetics each year are treated for chronic leg or foot ulcers in the Danish health sector.
      The treatment of these chronic wounds are associated with significant costs, as well as
      emotional, physical and financial.

      Vitamin D deficiency is a widespread problem, and it is estimated that worldwide there is 1
      billion people suffering from vitamin D deficiency. A Danish study from 2012 showed vitamin D
      deficiency in 52% of adults aged 30 60 years. Vitamin D deficiency is more common in
      diabetics with chronic foot or leg ulcers, when compared with non diabetics and diabetics
      without ulcers.

      Methods and materials

      48 diabetic patients with chronic foot ulcers will be included in the study. The patients
      will be recruited from the outpatient clinic, department of orthopaedic surgery at Zealand
      University Hospital, Denmark. The patients will randomly be divided into two groups,
      respectively treated with vitamin D or placebo.

      Expected outcome and perspectives

      The investigators expect that this study will show that supplementation with oral vitamin D,
      will result in a significant effect on wound treatment and healing for a large group of
      diabetic patients with chronic foot ulcers. This will contribute to a changed procedure in
      this specific group of patients, leading to measurement of vitamin D status and
      supplementation with vitamin D if needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Wound healing
time frame: 48 weeks or wound healing.
description: Wound healing, measured in square cm
measure: Vitamin D blod level status
time frame: 48 weeks or wound healing.
description: Vitamin D blod level status in intervention Group after supplementation.
arm group label: Vitamin D
arm group type: Experimental
description: supplementation with tablet 170 μg Vitamin D each day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, tablet with 20 μg Vitamin D each day.
intervention type: Dietary Supplement
intervention name: Vitamin D
description: Supplementation with tablet 170 μg Vitamin each day.
arm group label: Vitamin D
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo with tablet 20 μg Vitamin each day.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Max Halschou-Jensen, MD
role: Study Director
affiliation: Zeeland University Hospital, Denmark
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Vitamin D Deficiency
mesh term: Ulcer
mesh term: Vitamin D
sharing ipd: Undecided