<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/NCT01663519</url>
  </required_header>
  <id_info>
    <org_study_id>VGFOUGSB-9725 Regional R&amp;D</org_study_id>
    <nct_id>NCT01663519</nct_id>
  </id_info>
  <brief_title>Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg</brief_title>
  <official_title>Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients&#xD;
      at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1%&#xD;
      to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines&#xD;
      Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the&#xD;
      feet, education and prescription of insoles in combination with well fitting shoes are&#xD;
      supposed to decrease the risk of ulcers and prevent amputation. Further research is, however,&#xD;
      needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this&#xD;
      study is to compare three different types of insoles with respect to pressure distribution.&#xD;
      Every 6 months follow-up is assessed until 24 months is reached.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients included in the study were randomized into 3 different groups. Group number 1 and 2&#xD;
      got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55&#xD;
      shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and&#xD;
      in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out&#xD;
      of microcellular urethane. All patients were recommended to wear good walking shoes with a&#xD;
      semi rigid outer sole and stable heel counter. One and the same technician made the casting&#xD;
      and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks&#xD;
      after the first visit.&#xD;
&#xD;
      At deliverance base line measurement was assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In shoe plantar pressure measurement</measure>
    <time_frame>up to 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait analysis</measure>
    <time_frame>every 6 months until 24 months is reached</time_frame>
    <description>Optical tracking system with skin-mounted markers</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>every 6 months until 24 months is reached</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cost and cost analysis</measure>
    <time_frame>24 month</time_frame>
    <description>Calculation of costs for orthopaedic appliance in studied population</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Diabetic Foot</condition>
  <condition>Neuropathy</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Prefabricated insoles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Custom made insoles 35 shore</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>55 shore Custom made insoles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Custom made insoles 35 shore</intervention_name>
    <description>Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.</description>
    <arm_group_label>Custom made insoles 35 shore</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prefabricated insoles</intervention_name>
    <description>Prefabricated insoles</description>
    <arm_group_label>Prefabricated insoles</arm_group_label>
    <other_name>Bauerfeind GloboTec® 312750501400</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>55 shore Custom made insole</intervention_name>
    <description>Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.</description>
    <arm_group_label>55 shore Custom made insoles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  First time visitor to Dept of Prosthetics &amp; Orthotics&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Age &gt; 18 year&#xD;
&#xD;
          -  Be able to walk independently&#xD;
&#xD;
          -  Be able to read and understand Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ulcers&#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>Roy Tranberg, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Lundbergs laboratory for Orthopaedic Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lundbergs Laboratory for Orthopaedic Research</name>
      <address>
        <city>Gothenburg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://hdl.handle.net/2077/50860</url>
    <description>The Diabetic Foot - assessment and assistive devices</description>
  </link>
  <results_reference>
    <citation>Hellstrand Tang U, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial. J Clin Transl Endocrinol. 2014 Jul 24;1(4):121-132. doi: 10.1016/j.jcte.2014.06.002. eCollection 2014 Dec.</citation>
    <PMID>29159093</PMID>
  </results_reference>
  <results_reference>
    <citation>Tang UH, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers. Diabet Foot Ankle. 2015 Jun 17;6:27593. doi: 10.3402/dfa.v6.27593. eCollection 2015.</citation>
    <PMID>26087865</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Ulla Hellstrand Tang</investigator_full_name>
    <investigator_title>Certified Prosthetist &amp; Orthotist</investigator_title>
  </responsible_party>
  <keyword>Diabetic foot</keyword>
  <keyword>Offloading</keyword>
  <keyword>Prevention</keyword>
  <keyword>Orthotics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</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/NCT01663519
org study id: VGFOUGSB-9725 Regional R&D
nct id: NCT01663519
lead sponsor: 
has dmc: No
Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients
      at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1%
      to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines
      Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the
      feet, education and prescription of insoles in combination with well fitting shoes are
      supposed to decrease the risk of ulcers and prevent amputation. Further research is, however,
      needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this
      study is to compare three different types of insoles with respect to pressure distribution.
      Every 6 months follow-up is assessed until 24 months is reached.
Patients included in the study were randomized into 3 different groups. Group number 1 and 2
      got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55
      shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and
      in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out
      of microcellular urethane. All patients were recommended to wear good walking shoes with a
      semi rigid outer sole and stable heel counter. One and the same technician made the casting
      and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks
      after the first visit.

      At deliverance base line measurement was assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: In shoe plantar pressure measurement
time frame: up to 24 months
measure: Gait analysis
time frame: every 6 months until 24 months is reached
description: Optical tracking system with skin-mounted markers
measure: Health related quality of life
time frame: every 6 months until 24 months is reached
measure: Cost and cost analysis
time frame: 24 month
description: Calculation of costs for orthopaedic appliance in studied population
arm group label: Prefabricated insoles
arm group type: Experimental
description: Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
arm group label: Custom made insoles 35 shore
arm group type: Experimental
description: Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
arm group label: 55 shore Custom made insoles
arm group type: Experimental
description: Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
intervention type: Other
intervention name: Custom made insoles 35 shore
description: Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
arm group label: Custom made insoles 35 shore
intervention type: Other
intervention name: Prefabricated insoles
description: Prefabricated insoles
arm group label: Prefabricated insoles
other name: Bauerfeind GloboTec® 312750501400
intervention type: Other
intervention name: 55 shore Custom made insole
description: Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
arm group label: 55 shore Custom made insoles
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roy Tranberg, PhD
role: Study Chair
affiliation: Lundbergs laboratory for Orthopaedic Research
facility: 
country: Sweden
url: http://hdl.handle.net/2077/50860
description: The Diabetic Foot - assessment and assistive devices
citation: Hellstrand Tang U, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial. J Clin Transl Endocrinol. 2014 Jul 24;1(4):121-132. doi: 10.1016/j.jcte.2014.06.002. eCollection 2014 Dec.
PMID: 29159093
citation: Tang UH, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers. Diabet Foot Ankle. 2015 Jun 17;6:27593. doi: 10.3402/dfa.v6.27593. eCollection 2015.
PMID: 26087865
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Ulla Hellstrand Tang
investigator title: Certified Prosthetist & Orthotist
mesh term: Diabetic Foot