<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/NCT02995863</url>
  </required_header>
  <id_info>
    <org_study_id>UComplutenseMadrid</org_study_id>
    <nct_id>NCT02995863</nct_id>
  </id_info>
  <brief_title>This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.</brief_title>
  <official_title>Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy: a Prospective and Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</source>
  <brief_summary>
    <textblock>
      This research presents a randomized clinical trial which analyzes the efficacy of a rigid&#xD;
      rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot&#xD;
      patients. The hypothesis of the research is the use of a rigid rocker sole reduces the&#xD;
      recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2016</start_date>
  <completion_date type="Actual">May 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 10, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of diabetic foot ulcer</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene using the following grades: grade 0 (pre- or post-ulcerative lesion), grade 1 (partial/full-thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene) and grade 5 (whole foot gangrene</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ankle Joint movility</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The ankle joint is examined in the neutral position, with the patient prone; a vertical line is marked on the patient's skin from heel to midcalf, and the maxi- mum range of dorsiflexion in passive motion is mea- sured in degrees with a goniometer. The normal value for the ankle joint is a mobility &gt;90° of dorsi- flexion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility of the First metatarsal Joint</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Is examined with the patient in the supine position, and a horizontal line is drawn from the big toe to the heel. The maximum range of pas- sive dorsiflexion is recorded. The normal range of joint mobility is &gt;65° at rest and 30° when the patient is standing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subtalar Joint Movements</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>(inversion and eversion) are examined with the patient in a prone position, holding the calcaneus with one hand and the neck of the astragalus with the thumb and index finger of the other hand. Holding the astragalus rather than the tibia isolated the s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IPAQ (International Physical Activity Questionnaires)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The purpose of the International Physical Activity Questionnaires (IPAQ) is to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity. There are two versions of the questionnaire. The short version is suitable for use in national and regional surveillance systems and the long version provide more detailed information often required in research work or for evaluation purposes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot Type</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The validated protocol of the Foot Posture Index-6 involves the rating of three criteria in the rearfoot: Talar head palpation,Supra- and infra-lateral malleolar curvature and Calcaneal frontal plane position. In addition, there are three criteria on the forefoot: Prominence in the region of the talonavicular joint (TNJ), Congruence of the medial longitudinal arch (MLA), Abduction/adduction of the forefoot on the rearfoot. Each item is graded by a five-point Likert-type, from -2 to +2: 0 for neutral, with a minimum score of -2 for clear signs of supination, and +2 for positive signs of pronation. The final FPI-6 score will be a whole number between -12 and +12. A total FPI-6 score between 0 and +5 indicates a neutral foot, a score of above +6 indicates a pronated or highly pronated foot, and a score between -1 and -12 indicates a supinated or highly supinated foot.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deformities</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Forefoot deformities were considered when the foot presented any of the following: hallux valgus, Tailor's bunion; toe contractures (hammer-toe, claw-toe or mallet-toe deformities); subluxation or dislocation of the metatarsophalangeal joints (overlapped toe and prominent metatarsal heads).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle - Brachial Index (ABI)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The dorsalis pedis artery was used for recording ankle values. The ABI were calculated with the equations of the ankle pressure readings divided by the highest brachial reading between the right and left arms. We considered Peripheral Arterial Disease to have an ABI value less than 0.9; normal ABI values were between 0.9 and 1.39, and an ABI value ≥1.4 was considered poorly compressible vessels related to medial arterial calcification in distal arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensorimotor neuropathy</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Sensorimotor neuropathy was diagnosed by evaluation using a Semmes-Weinstein 5.07/10 g monofilament and a biothesiometer (both from Novalab Iberica, Madrid, Spain). Patients who did not feel 1 of the 2 tests were diagnosed with neuropathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Questionnaire</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Measurements about time of use of footwear either at home or outdoor. Normal value ranges are: never, 1 day per week, 1 to 3 day per week, 4 to 5 days per week and 6 to 7 days per week.&#xD;
And measurements about how many hours per day the patient wear the footwear, the normal value ranges are: less than 1 hour, 1 to 3 hours per day, 4 to 7 hours per day, 8 to 11 hours per day and more than 12 hours per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toe - Brachial Index (TBI)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The ABI and the TBI were calculated with the equations of the ankle or toe pressure readings divided by the highest brachial reading between the right and left arms. We considered PAD to have a TBI value less than 0.7; normal TBI values were between 0.7 and 0.99, and TBI ≥ 1 was considered distal arteries calcification.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Diabetic Foot</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rigid rocker sole footwear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Therapeutic footwear</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rigid Rocker Sole Footwear</intervention_name>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therapeutic Footwear</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.&#xD;
&#xD;
          -  Adult patients of both sexes.&#xD;
&#xD;
          -  Peripheral neuropathy patients.&#xD;
&#xD;
          -  Patients without wounds or ulcers at the examination time.&#xD;
&#xD;
          -  Patients with a foot ulcers history.&#xD;
&#xD;
          -  Patients with or without minor amputation prior to the inclusion time in the present&#xD;
             study.&#xD;
&#xD;
          -  Patients who don´t need gait support mechanisms such as walking sticks, crutches,&#xD;
             splints or any other devices which interferes with the autonomous development of the&#xD;
             gait.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mayor amputation.&#xD;
&#xD;
          -  Patients with rheumatic disease that affect the feet.&#xD;
&#xD;
          -  Patients with peripheral neuropathy of different etiology to Diabetes mellitus.&#xD;
&#xD;
          -  Patients with several critical ischemia criteria, defined by TACS II guideline.&#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>
  <location>
    <facility>
      <name>Clínica Universitaria de Podología de la Universidad Complutense de Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>May 10, 2018</last_update_submitted>
  <last_update_submitted_qc>May 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Complutense de Madrid</investigator_affiliation>
    <investigator_full_name>Mateo López Moral</investigator_full_name>
    <investigator_title>Clinical Research</investigator_title>
  </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>
  </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/NCT02995863
org study id: UComplutenseMadrid
nct id: NCT02995863
lead sponsor: 
This research presents a randomized clinical trial which analyzes the efficacy of a rigid
      rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot
      patients. The hypothesis of the research is the use of a rigid rocker sole reduces the
      recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Presence of diabetic foot ulcer
time frame: through study completion, an average of 6 months
description: The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene using the following grades: grade 0 (pre- or post-ulcerative lesion), grade 1 (partial/full-thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene) and grade 5 (whole foot gangrene
measure: Ankle Joint movility
time frame: through study completion, an average of 6 months
description: The ankle joint is examined in the neutral position, with the patient prone; a vertical line is marked on the patient's skin from heel to midcalf, and the maxi- mum range of dorsiflexion in passive motion is mea- sured in degrees with a goniometer. The normal value for the ankle joint is a mobility >90° of dorsi- flexion.
measure: Mobility of the First metatarsal Joint
time frame: through study completion, an average of 6 months
description: Is examined with the patient in the supine position, and a horizontal line is drawn from the big toe to the heel. The maximum range of pas- sive dorsiflexion is recorded. The normal range of joint mobility is >65° at rest and 30° when the patient is standing.
measure: Subtalar Joint Movements
time frame: through study completion, an average of 6 months
description: (inversion and eversion) are examined with the patient in a prone position, holding the calcaneus with one hand and the neck of the astragalus with the thumb and index finger of the other hand. Holding the astragalus rather than the tibia isolated the s
measure: IPAQ (International Physical Activity Questionnaires)
time frame: through study completion, an average of 6 months
description: The purpose of the International Physical Activity Questionnaires (IPAQ) is to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity. There are two versions of the questionnaire. The short version is suitable for use in national and regional surveillance systems and the long version provide more detailed information often required in research work or for evaluation purposes.
measure: Foot Type
time frame: through study completion, an average of 6 months
description: The validated protocol of the Foot Posture Index-6 involves the rating of three criteria in the rearfoot: Talar head palpation,Supra- and infra-lateral malleolar curvature and Calcaneal frontal plane position. In addition, there are three criteria on the forefoot: Prominence in the region of the talonavicular joint (TNJ), Congruence of the medial longitudinal arch (MLA), Abduction/adduction of the forefoot on the rearfoot. Each item is graded by a five-point Likert-type, from -2 to +2: 0 for neutral, with a minimum score of -2 for clear signs of supination, and +2 for positive signs of pronation. The final FPI-6 score will be a whole number between -12 and +12. A total FPI-6 score between 0 and +5 indicates a neutral foot, a score of above +6 indicates a pronated or highly pronated foot, and a score between -1 and -12 indicates a supinated or highly supinated foot.
measure: Deformities
time frame: through study completion, an average of 6 months
description: Forefoot deformities were considered when the foot presented any of the following: hallux valgus, Tailor's bunion; toe contractures (hammer-toe, claw-toe or mallet-toe deformities); subluxation or dislocation of the metatarsophalangeal joints (overlapped toe and prominent metatarsal heads).
measure: Ankle - Brachial Index (ABI)
time frame: through study completion, an average of 6 months
description: Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The dorsalis pedis artery was used for recording ankle values. The ABI were calculated with the equations of the ankle pressure readings divided by the highest brachial reading between the right and left arms. We considered Peripheral Arterial Disease to have an ABI value less than 0.9; normal ABI values were between 0.9 and 1.39, and an ABI value ≥1.4 was considered poorly compressible vessels related to medial arterial calcification in distal arteries.
measure: Sensorimotor neuropathy
time frame: through study completion, an average of 6 months
description: Sensorimotor neuropathy was diagnosed by evaluation using a Semmes-Weinstein 5.07/10 g monofilament and a biothesiometer (both from Novalab Iberica, Madrid, Spain). Patients who did not feel 1 of the 2 tests were diagnosed with neuropathy.
measure: Physical Activity Questionnaire
time frame: through study completion, an average of 6 months
description: Measurements about time of use of footwear either at home or outdoor. Normal value ranges are: never, 1 day per week, 1 to 3 day per week, 4 to 5 days per week and 6 to 7 days per week.
And measurements about how many hours per day the patient wear the footwear, the normal value ranges are: less than 1 hour, 1 to 3 hours per day, 4 to 7 hours per day, 8 to 11 hours per day and more than 12 hours per day.
measure: Toe - Brachial Index (TBI)
time frame: through study completion, an average of 6 months
description: Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The ABI and the TBI were calculated with the equations of the ankle or toe pressure readings divided by the highest brachial reading between the right and left arms. We considered PAD to have a TBI value less than 0.7; normal TBI values were between 0.7 and 0.99, and TBI ≥ 1 was considered distal arteries calcification.
arm group label: Experimental Group
arm group type: Experimental
description: Rigid rocker sole footwear
arm group label: Control Group
arm group type: Active Comparator
description: Therapeutic footwear
intervention type: Device
intervention name: Rigid Rocker Sole Footwear
arm group label: Experimental Group
intervention type: Device
intervention name: Therapeutic Footwear
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Complutense de Madrid
investigator full name: Mateo López Moral
investigator title: Clinical Research
mesh term: Diabetic Foot
mesh term: Foot Ulcer