<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/NCT03254095</url>
  </required_header>
  <id_info>
    <org_study_id>FADEUP_PhD_AdéritoSeixas#1</org_study_id>
    <nct_id>NCT03254095</nct_id>
  </id_info>
  <brief_title>Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.</brief_title>
  <official_title>Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Hospitalar do Porto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade do Porto</source>
  <brief_summary>
    <textblock>
      Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to&#xD;
      individuals and the society and it is expected to be the 7th leading cause of death in 2030.&#xD;
      Diabetes related complications manifest in many body parts, often in the foot, due to reduced&#xD;
      blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar&#xD;
      pressures during walking contribute to the development of foot ulcers and foot ulcer&#xD;
      recurrence. Emerging studies also point skin temperature as another predictor of foot&#xD;
      ulceration. However, the number of studies including prediction models of plantar pressure&#xD;
      and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic&#xD;
      foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue,&#xD;
      foot deformities and other diabetes related characteristics have been related to plantar&#xD;
      pressure measurements but not to foot skin temperature measurements, and the relation between&#xD;
      skin temperature and plantar pressure has not been much explored in the literature. The role&#xD;
      of these variables in the development of foot ulceration needs further attention, especially&#xD;
      in patients with history of foot ulcers has they are at the highest risk to develop a foot&#xD;
      ulcer.&#xD;
&#xD;
      Therefore, the goal of this research is to determine which variables can be used to predict&#xD;
      plantar pressure and skin temperature and which factors are associated with the development&#xD;
      of foot ulcers in patients with established diagnosis of diabetic foot. The associations&#xD;
      between skin temperature and plantar pressure will also be addressed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Skin temperature</measure>
    <time_frame>At study entry</time_frame>
    <description>After an acclimation period of 10 minutes, skin temperature of the sole and dorsum of the foot will be assessed with a thermographic camera. Thermograms will be captured before, immediately after and five minutes after a two-minute cold stress test using an aluminium plaque.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barefoot plantar pressure</measure>
    <time_frame>At study entry</time_frame>
    <description>Barefoot plantar pressure will be assessed using a pressure platform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients developing a foot ulcer</measure>
    <time_frame>One year after enrollment</time_frame>
    <description>The occurrence of foot ulceration will be assessed during a period of 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ankle mobility</measure>
    <time_frame>At study entry</time_frame>
    <description>Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hallux active extension range of movement</measure>
    <time_frame>At study entry</time_frame>
    <description>Hallux active extension mobility will be assessed with a goniometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soft tissue hardness</measure>
    <time_frame>At study entry</time_frame>
    <description>Soft tissue hardness will be assessed with a durometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-shoe plantar pressure</measure>
    <time_frame>At study entry</time_frame>
    <description>In-shoe plantar pressure will be assessed using an insole system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to ulceration</measure>
    <time_frame>At study entry</time_frame>
    <description>The time to ulcer occurrence will be assessed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Disease duration</measure>
    <time_frame>At study entry</time_frame>
    <description>Diabetes duration until the assessment day will be noted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of diabetes</measure>
    <time_frame>At study entry</time_frame>
    <description>The type of diabetes (Type I or Type II) will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Foot deformity</measure>
    <time_frame>At study entry</time_frame>
    <description>The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Amputation</measure>
    <time_frame>At study entry</time_frame>
    <description>The presence of minor amputation will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Neuropathy</measure>
    <time_frame>At study entry</time_frame>
    <description>The presence of neuropathy will be assessed according to the criteria of the International Working Group on the Diabetic Foot.</description>
  </other_outcome>
  <other_outcome>
    <measure>Peripheral artery disease</measure>
    <time_frame>At study entry</time_frame>
    <description>Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Generic health status</measure>
    <time_frame>At study entry</time_frame>
    <description>The generic health status will be assessed with the EQ-5D-5L instrument.</description>
  </other_outcome>
  <other_outcome>
    <measure>Age</measure>
    <time_frame>At study entry</time_frame>
    <description>The age of participants at the assessment day will be noted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Height</measure>
    <time_frame>At study entry</time_frame>
    <description>The height of participants at the assessment day will be noted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>At study entry</time_frame>
    <description>The weight of participants at the assessment day will be noted.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index</measure>
    <time_frame>At study entry</time_frame>
    <description>Body mass index will be calculated from the height and weight of the participants.</description>
  </other_outcome>
  <enrollment type="Actual">54</enrollment>
  <condition>Diabetic Foot</condition>
  <condition>Diabetes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with established diagnosis of diabetic foot. Diabetic Foot is related to&#xD;
        infection, ulceration or destruction of tissues of the foot associated with neuropathy&#xD;
        and/or peripheral artery disease in the lower extremity of people with diabetes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (over 18 years)&#xD;
&#xD;
          -  Diagnosed as diabetic foot patient&#xD;
&#xD;
          -  Able to walk 10 meters without assistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-cooperating patients&#xD;
&#xD;
          -  Patients with major amputations&#xD;
&#xD;
          -  Patients with a draining ulcer and/or infection&#xD;
&#xD;
          -  Patients with cognitive impairments&#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>Adérito RD Seixas, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Porto</affiliation>
  </overall_official>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade do Porto</investigator_affiliation>
    <investigator_full_name>Adérito Seixas</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Skin temperature</keyword>
  <keyword>Plantar pressure</keyword>
  <keyword>Diabetic foot</keyword>
  <keyword>Tissue hardness</keyword>
  <keyword>Neuropathy</keyword>
  <keyword>Peripheral artery disease</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/NCT03254095
org study id: FADEUP_PhD_AdéritoSeixas#1
nct id: NCT03254095
lead sponsor: 
collaborator: 
Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to
      individuals and the society and it is expected to be the 7th leading cause of death in 2030.
      Diabetes related complications manifest in many body parts, often in the foot, due to reduced
      blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar
      pressures during walking contribute to the development of foot ulcers and foot ulcer
      recurrence. Emerging studies also point skin temperature as another predictor of foot
      ulceration. However, the number of studies including prediction models of plantar pressure
      and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic
      foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue,
      foot deformities and other diabetes related characteristics have been related to plantar
      pressure measurements but not to foot skin temperature measurements, and the relation between
      skin temperature and plantar pressure has not been much explored in the literature. The role
      of these variables in the development of foot ulceration needs further attention, especially
      in patients with history of foot ulcers has they are at the highest risk to develop a foot
      ulcer.

      Therefore, the goal of this research is to determine which variables can be used to predict
      plantar pressure and skin temperature and which factors are associated with the development
      of foot ulcers in patients with established diagnosis of diabetic foot. The associations
      between skin temperature and plantar pressure will also be addressed.
observational model: Cohort
time perspective: Prospective
measure: Skin temperature
time frame: At study entry
description: After an acclimation period of 10 minutes, skin temperature of the sole and dorsum of the foot will be assessed with a thermographic camera. Thermograms will be captured before, immediately after and five minutes after a two-minute cold stress test using an aluminium plaque.
measure: Barefoot plantar pressure
time frame: At study entry
description: Barefoot plantar pressure will be assessed using a pressure platform.
measure: Percentage of patients developing a foot ulcer
time frame: One year after enrollment
description: The occurrence of foot ulceration will be assessed during a period of 1 year.
measure: Ankle mobility
time frame: At study entry
description: Active ankle mobility (dorsiflexion and plantarflexion) will be assessed with a goniometer.
measure: Hallux active extension range of movement
time frame: At study entry
description: Hallux active extension mobility will be assessed with a goniometer.
measure: Soft tissue hardness
time frame: At study entry
description: Soft tissue hardness will be assessed with a durometer.
measure: In-shoe plantar pressure
time frame: At study entry
description: In-shoe plantar pressure will be assessed using an insole system.
measure: Time to ulceration
time frame: At study entry
description: The time to ulcer occurrence will be assessed.
measure: Disease duration
time frame: At study entry
description: Diabetes duration until the assessment day will be noted.
measure: Type of diabetes
time frame: At study entry
description: The type of diabetes (Type I or Type II) will be assessed.
measure: Foot deformity
time frame: At study entry
description: The presence of claw toes, hammer toes, hallux valgus, flat foot, increased foot arch and Charcot will be assessed.
measure: Amputation
time frame: At study entry
description: The presence of minor amputation will be assessed.
measure: Neuropathy
time frame: At study entry
description: The presence of neuropathy will be assessed according to the criteria of the International Working Group on the Diabetic Foot.
measure: Peripheral artery disease
time frame: At study entry
description: Peripheral artery disease signs - an absence of foot pulses and intermittent claudication - will be assessed.
measure: Generic health status
time frame: At study entry
description: The generic health status will be assessed with the EQ-5D-5L instrument.
measure: Age
time frame: At study entry
description: The age of participants at the assessment day will be noted.
measure: Height
time frame: At study entry
description: The height of participants at the assessment day will be noted.
measure: Weight
time frame: At study entry
description: The weight of participants at the assessment day will be noted.
measure: Body mass index
time frame: At study entry
description: Body mass index will be calculated from the height and weight of the participants.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adérito RD Seixas, MSc
role: Principal Investigator
affiliation: Universidade do Porto
responsible party type: Principal Investigator
investigator affiliation: Universidade do Porto
investigator full name: Adérito Seixas
investigator title: PhD Student
mesh term: Diabetic Foot