<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/NCT02211495</url>
  </required_header>
  <id_info>
    <org_study_id>14/SC/0084</org_study_id>
    <secondary_id>14HH1901</secondary_id>
    <nct_id>NCT02211495</nct_id>
  </id_info>
  <brief_title>ULCERS - Electrical Stimulation in Diabetic Foot Ulceration</brief_title>
  <official_title>Electrical Stimulation in Diabetic Foot Ulceration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</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 investigators hypothesise that use of a medical device, that increases blood flow to the&#xD;
      foot, will speed up ulcer healing in symptomatic diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects&#xD;
      that diabetes will be the 7th leading cause of death. Diabetic foot ulcers are estimated to&#xD;
      occur in 15% of all patients with diabetes, often co-existing with neuropathy and peripheral&#xD;
      vascular disease which compromise the limb's ability to heal. Foot infections in this cohort&#xD;
      are common, and diabetic foot ulcers serve as a portal for infective organisms to enter the&#xD;
      body. Unchecked, infection can spread contiguously to involve underlying tissues, including&#xD;
      bone. A diabetic foot infection is often the pivotal event leading to gangrene and lower&#xD;
      extremity amputation. Diabetes accounts for over one million leg amputations every year, and&#xD;
      represents 60% of all amputations in developed countries.&#xD;
&#xD;
      Due to the potential for rapid progression of infection, and the gravity of potential&#xD;
      complications, diabetic foot problems are handled aggressively in the community, with a low&#xD;
      threshold for referral to secondary care. Out-patient clinics involve a multidisciplinary&#xD;
      team of clinicians, podiatrists and vascular surgeons. Good foot care is taught to all&#xD;
      diabetic patients, and treatment with antibiotics, debridement and revascularisation should&#xD;
      occur as a matter of urgency where appropriate.&#xD;
&#xD;
      The device to be tested mimics the effect of walking by making the foot twitch- it increases&#xD;
      blood flow to the limb and exercises the leg muscles. It is hypothesised that increasing&#xD;
      blood flow to the limb, much as surgical revascularisation, will aid the legs ability to heal&#xD;
      and fight infection. After training, it can be used by patients on themselves and is suitable&#xD;
      for out-patient therapy.&#xD;
&#xD;
      The investigators wish to evaluate both the short- and longer-term effects of a neuromuscular&#xD;
      stimulator on diabetic foot ulceration as a therapeutic intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Day Until 50% Healing of Leg Ulcer</measure>
    <time_frame>8 weeks</time_frame>
    <description>Time to 50% healing of leg ulcer, as measured by volume (3D camera)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (PAID, EQ5D, VAS, SF-12)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID (&quot;Problem Areas in Diabetes&quot;) - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS (&quot;visual analogue scale&quot;) - For pain intensity, the scale is anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100) SF 12 (&quot;short form 12&quot;) - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>No device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with best medical therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GEKO device</intervention_name>
    <description>Placed on the lateral aspect of the knee, when activated it causes the leg to twitch</description>
    <arm_group_label>Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Medical Therapy</intervention_name>
    <description>Seen in outpatient clinic for wound care and ongoing advice</description>
    <arm_group_label>Device</arm_group_label>
    <arm_group_label>No device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  18+ years old&#xD;
&#xD;
          -  Type 2 diabetes on best medical therapy&#xD;
&#xD;
          -  Active foot ulceration, present &lt;3 months Exclusion criteria&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Metal implants in the legs (below knee)&#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>Kate Williams</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetic Foot Clinic, Praed Street, Paddington</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <results_first_submitted>September 18, 2019</results_first_submitted>
  <results_first_submitted_qc>November 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2020</results_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot</keyword>
  <keyword>Ulcer healing</keyword>
  <keyword>Medical device to increase blood flow in foot</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>No Device</title>
          <description>Treated with best medical therapy&#xD;
Best Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice</description>
        </group>
        <group group_id="P2">
          <title>Device</title>
          <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.&#xD;
GEKO device: Placed on the lateral aspect of the knee, when activated it causes the leg to twitch&#xD;
Best Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Device</title>
          <description>Medical therapy</description>
        </group>
        <group group_id="B2">
          <title>Device</title>
          <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" lower_limit="56" upper_limit="76"/>
                    <measurement group_id="B2" value="69.5" lower_limit="49" upper_limit="87"/>
                    <measurement group_id="B3" value="67" lower_limit="49" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="4"/>
                    <count group_id="B3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Day Until 50% Healing of Leg Ulcer</title>
        <description>Time to 50% healing of leg ulcer, as measured by volume (3D camera)</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Device</title>
            <description>Medical therapy only.</description>
          </group>
          <group group_id="O2">
            <title>Device</title>
            <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Day Until 50% Healing of Leg Ulcer</title>
          <description>Time to 50% healing of leg ulcer, as measured by volume (3D camera)</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="5"/>
                    <measurement group_id="O2" value="30" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (PAID, EQ5D, VAS, SF-12)</title>
        <description>Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID (&quot;Problem Areas in Diabetes&quot;) - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS (&quot;visual analogue scale&quot;) - For pain intensity, the scale is anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100) SF 12 (&quot;short form 12&quot;) - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Device (Week 0)</title>
            <description>Medical therapy, no device.</description>
          </group>
          <group group_id="O2">
            <title>No Device (Week 6)</title>
            <description>Medical therapy, no device, week 6.</description>
          </group>
          <group group_id="O3">
            <title>Device (Week 0)</title>
            <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg.&#xD;
Week 0</description>
          </group>
          <group group_id="O4">
            <title>Device (Week 6)</title>
            <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week, week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (PAID, EQ5D, VAS, SF-12)</title>
          <description>Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID (&quot;Problem Areas in Diabetes&quot;) - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS (&quot;visual analogue scale&quot;) - For pain intensity, the scale is anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100) SF 12 (&quot;short form 12&quot;) - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PAID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="14"/>
                    <measurement group_id="O2" value="13" spread="1"/>
                    <measurement group_id="O3" value="21.2" spread="7"/>
                    <measurement group_id="O4" value="17.3" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ5D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".54" spread=".4"/>
                    <measurement group_id="O2" value=".7" spread=".2"/>
                    <measurement group_id="O3" value=".18" spread=".4"/>
                    <measurement group_id="O4" value=".4" spread=".4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="13"/>
                    <measurement group_id="O2" value="60" spread="14"/>
                    <measurement group_id="O3" value="37" spread="38"/>
                    <measurement group_id="O4" value="55" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1" spread="12"/>
                    <measurement group_id="O2" value="67" spread="9"/>
                    <measurement group_id="O3" value="66" spread="14"/>
                    <measurement group_id="O4" value="72" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>No Device</title>
          <description>Medical therapy, no device.</description>
        </group>
        <group group_id="E2">
          <title>Device</title>
          <description>As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Miss Kate Williams</name_or_title>
      <organization>Imperial College London</organization>
      <email>k.williams@imperial.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02211495
org study id: 14/SC/0084
secondary id: 14HH1901
nct id: NCT02211495
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesise that use of a medical device, that increases blood flow to the
      foot, will speed up ulcer healing in symptomatic diabetes
Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects
      that diabetes will be the 7th leading cause of death. Diabetic foot ulcers are estimated to
      occur in 15% of all patients with diabetes, often co-existing with neuropathy and peripheral
      vascular disease which compromise the limb's ability to heal. Foot infections in this cohort
      are common, and diabetic foot ulcers serve as a portal for infective organisms to enter the
      body. Unchecked, infection can spread contiguously to involve underlying tissues, including
      bone. A diabetic foot infection is often the pivotal event leading to gangrene and lower
      extremity amputation. Diabetes accounts for over one million leg amputations every year, and
      represents 60% of all amputations in developed countries.

      Due to the potential for rapid progression of infection, and the gravity of potential
      complications, diabetic foot problems are handled aggressively in the community, with a low
      threshold for referral to secondary care. Out-patient clinics involve a multidisciplinary
      team of clinicians, podiatrists and vascular surgeons. Good foot care is taught to all
      diabetic patients, and treatment with antibiotics, debridement and revascularisation should
      occur as a matter of urgency where appropriate.

      The device to be tested mimics the effect of walking by making the foot twitch- it increases
      blood flow to the limb and exercises the leg muscles. It is hypothesised that increasing
      blood flow to the limb, much as surgical revascularisation, will aid the legs ability to heal
      and fight infection. After training, it can be used by patients on themselves and is suitable
      for out-patient therapy.

      The investigators wish to evaluate both the short- and longer-term effects of a neuromuscular
      stimulator on diabetic foot ulceration as a therapeutic intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Day Until 50% Healing of Leg Ulcer
time frame: 8 weeks
description: Time to 50% healing of leg ulcer, as measured by volume (3D camera)
measure: Quality of Life (PAID, EQ5D, VAS, SF-12)
time frame: 6 weeks
description: Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID ("Problem Areas in Diabetes") - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS ("visual analogue scale") - For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100) SF 12 ("short form 12") - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health
arm group label: No device
arm group type: Active Comparator
description: Treated with best medical therapy
arm group label: Device
arm group type: Experimental
description: As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.
intervention type: Device
intervention name: GEKO device
description: Placed on the lateral aspect of the knee, when activated it causes the leg to twitch
arm group label: Device
intervention type: Other
intervention name: Best Medical Therapy
description: Seen in outpatient clinic for wound care and ongoing advice
arm group label: Device
arm group label: No device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kate Williams
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 