xml: <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/NCT05964712</url>
    </required_header>
    <id_info>
      <org_study_id>40C901</org_study_id>
      <nct_id>NCT05964712</nct_id>
    </id_info>
    <brief_title>Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study</brief_title>
    <acronym>ACROMORFO</acronym>
    <official_title>Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Auxologico Italiano</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Politecnico di Milano</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Istituto Auxologico Italiano</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Acromegaly is a rare chronic disease due to excessive secretion of growth hormone (GH) and&#xD;
        insulin-like growth factor-I (IGF-I), caused in over 98% of cases by GH-secreting pituitary&#xD;
        adenoma. Prolonged exposure to GH/IGF-I excess is the cause of increased mortality and&#xD;
        morbidity in these patients. Arthropathy occurs in about 75% of acromegalic patients. Any&#xD;
        joint may be affected, with the development of osteoarthritis, arthralgia, and an increase in&#xD;
        fracture risk.&#xD;
  &#xD;
        The aims of the present project are to evaluate the dimensions of hands and feet with the 3D&#xD;
        scanner method and to perform a quantitative analysis of movement through Gait Analysis&#xD;
        technique in de novo patients with acromegaly (group # 1) and in patients with different&#xD;
        disease status (group #2).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an observational, prospective study that aims to evaluate the effect of acromegalic&#xD;
        disease and medical/surgical therapy on acral morpho-functional alterations.&#xD;
  &#xD;
        To outline the morphological characteristics of the extremities (hands and feet), a&#xD;
        three-dimensional laser scanning system will be used able to measure the geometrical and&#xD;
        volumetric characteristics of the hands and feet of these subjects. The three-dimensional&#xD;
        scanning system that will be used is the portable FastScan system (marketed by Rodin),&#xD;
        previously used for the volumetric evaluation of the lower and upper limbs of subjects&#xD;
        suffering from lymphedema and lipedema. The processing of the image and the parameters will&#xD;
        be carried out through two softwares: Rodin4DScan, which carries out the reconstruction of&#xD;
        the shape after the scan, and Rodin4D, which allows the construction of the final shape and&#xD;
        allows the processing of the various parameters to the morphology of the extremity.&#xD;
  &#xD;
        The following tests will be used to characterize posture and balance control during walking:&#xD;
  &#xD;
          -  maintenance of the bipedal indifferent orthostatic posture, with open and closed eyes;&#xD;
  &#xD;
          -  walking on level ground, barefoot, at natural speed (10 m walking test)&#xD;
  &#xD;
        The instrumentation (BTS GAITLAB) that will be used consists of:&#xD;
  &#xD;
          -  8-camera stereophotogrammetric system (SMART DX, BTS-Bioengineering, IT);&#xD;
  &#xD;
          -  two dynamometric platforms (AMTI, USA);&#xD;
  &#xD;
          -  a baropodometric platform (P-WALK; BTS-Bioengineering, IT).&#xD;
  &#xD;
        The variables analyzed will be divided according to the administered tests:&#xD;
  &#xD;
          1. maintenance of the orthostatic posture: anteroposterior and mediolateral excursion of&#xD;
             the center of pressure, speed of displacement of the center of pressure, length of&#xD;
             postural ball and distribution of plantar pressures;&#xD;
  &#xD;
          2. gait: spatio-temporal parameters, kinematics of trunk and joints of lower limbs, ground&#xD;
             reaction forces, moments and joint powers.&#xD;
  &#xD;
        A functional evaluation of the foot will be also performed positioning the patient&#xD;
        prone/supine on the bed and measuring several joint angles.&#xD;
  &#xD;
        The measurement will be supported by a video from which images can be subsequently processed&#xD;
        to trace and obtain the joint angles.&#xD;
  &#xD;
        For the functional evaluation of the hand, the patient will be evaluated with the following&#xD;
        outcome measures:&#xD;
  &#xD;
          1. Algo-functional index of the hand according to Dreiser, which analyzes the ability to&#xD;
             execute some gestures of daily life;&#xD;
  &#xD;
          2. Duruöz index, questionnaire for assessing functional impairment of hand.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 18, 2019</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Change in serum concentration of GH and IGF1</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>Serum concentration of GH and IGF1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in postural</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>The postural evaluation was performed for 60 seconds while the participants were standing on a baropodometric platform (P-Walk, BTSBioengineering, Italy). They were instructed to maintain an upright position, with their eyes focused on a 6 cm black circle placed at their individual eye level, at a distance of 1.5 meters. Subsequently, they were asked to repeat the same task with their eyes closed. To avoid any learning or fatigue effects, two evaluations were acquired with open eyes and two with closed eyes, and between each trial, the subjects were allowed to rest and sit for 2 minutes, maintaining the foot position during the tests.&#xD;
  Postural parameters were calculated using dedicated software (G-Studio, BTS, Italy). The relative range of the center of pressure track length is essentially the difference between the maximum and minimum CoP position in the anterior-posterior and medial-lateral (ML) directions during the maintenance of the upright posture.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gait analysis</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>All participants were evaluated with 3D-Gait Analysis using an optoelectronic system composed of eight cameras (SMARTDX, BTSBioengineering, Italy) set at 100 Hz, and two force platforms (AMTI, USA). To evaluate the kinematics of each body segment, passive markers were positioned on the participants' body, as described by Davis III et al., and the underlying skeletal model was scaled on behalf of anthropometric data (height, weight, tibial length, distance between the femoral condyles or diameter of the knee, distance between the malleoli or diameter of the ankle, distance between the anterior iliac spines and thickness of the pelvis).&#xD;
  After placing the markers, the participants were asked to walk barefoot at self-selected speed along a walkway where the force platforms were embedded. Kinematic and kinetic data were collected for each individual from at least five trials to guarantee the reproducibility of the results.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in function of the foot - angle ankle joint</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the ankle joint</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in function of the foot - angle subtalar joint</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the subtalar joint</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in function of the foot - angle metatarsophalangeal joint of the big toe</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the metatarsophalangeal joint of the big toe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Function of the hand - Dreiser functional index</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>Algo-functional index of the hand according to Dreiser functional index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Function of the hand - Duruöz hand index</measure>
      <time_frame>At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1</time_frame>
      <description>Algo-functional index of the hand according to Duruöz hand index</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Acromegaly</condition>
    <arm_group>
      <arm_group_label>Population # 1</arm_group_label>
      <description>De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Population # 2</arm_group_label>
      <description>Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Medical surgery therapy</intervention_name>
      <description>De novo patients with acromegaly will undergo medical/surgical therapy of this disease, according to the guidelines of the Endocrine Society. In this population (group #1) morpho-functional examinations together with the evaluation of the stage of the disease, with serum dosage of GH and IGF-1, will be performed at baseline and at months 3, 6 and 12 after initiating the treatment.</description>
      <arm_group_label>Population # 1</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        serum dosage of GH and IGF-1&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Group #1: De novo patients with acromegaly, diagnosed according to Endocrine Society&#xD;
          guidelines, aged equal or above 18 years old;&#xD;
  &#xD;
          Group #2: Acromegalic patients with different disease status (active disease despite&#xD;
          ongoing therapies, controlled disease under medical therapy, and disease remission), aged&#xD;
          equal or above 18 years old&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  De novo patients with acromegaly (group # 1), diagnosed according to Endocrine Society&#xD;
               guidelines,&#xD;
  &#xD;
            -  Age equal to18 years or older&#xD;
  &#xD;
            -  Acromegalic patients with different disease status (group #2)&#xD;
  &#xD;
            -  Age equal to18 years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiorespiratory, neurological or musculoskeletal disorder&#xD;
  &#xD;
            -  Previous orthopaedic surgery&#xD;
  &#xD;
            -  Previous lower limbs traumatic injuries&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Giovanni Vitale</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istituto Auxologico Italiano IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sara Farina, Doctor</last_name>
      <phone>+393386822298</phone>
      <email>sara.farina@unimi.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istituto Auxologico Italiano IRCCS San Luca</name>
        <address>
          <city>Milano</city>
          <zip>20149</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giovanni Vitale</last_name>
        <email>g.vitale@auxologico.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</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>Acromegaly</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964712
  org study id: 40C901
  nct id: NCT05964712
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Acromegaly is a rare chronic disease due to excessive secretion of growth hormone (GH) and
        insulin-like growth factor-I (IGF-I), caused in over 98% of cases by GH-secreting pituitary
        adenoma. Prolonged exposure to GH/IGF-I excess is the cause of increased mortality and
        morbidity in these patients. Arthropathy occurs in about 75% of acromegalic patients. Any
        joint may be affected, with the development of osteoarthritis, arthralgia, and an increase in
        fracture risk.
  
        The aims of the present project are to evaluate the dimensions of hands and feet with the 3D
        scanner method and to perform a quantitative analysis of movement through Gait Analysis
        technique in de novo patients with acromegaly (group # 1) and in patients with different
        disease status (group #2).
  This is an observational, prospective study that aims to evaluate the effect of acromegalic
        disease and medical/surgical therapy on acral morpho-functional alterations.
  
        To outline the morphological characteristics of the extremities (hands and feet), a
        three-dimensional laser scanning system will be used able to measure the geometrical and
        volumetric characteristics of the hands and feet of these subjects. The three-dimensional
        scanning system that will be used is the portable FastScan system (marketed by Rodin),
        previously used for the volumetric evaluation of the lower and upper limbs of subjects
        suffering from lymphedema and lipedema. The processing of the image and the parameters will
        be carried out through two softwares: Rodin4DScan, which carries out the reconstruction of
        the shape after the scan, and Rodin4D, which allows the construction of the final shape and
        allows the processing of the various parameters to the morphology of the extremity.
  
        The following tests will be used to characterize posture and balance control during walking:
  
          -  maintenance of the bipedal indifferent orthostatic posture, with open and closed eyes;
  
          -  walking on level ground, barefoot, at natural speed (10 m walking test)
  
        The instrumentation (BTS GAITLAB) that will be used consists of:
  
          -  8-camera stereophotogrammetric system (SMART DX, BTS-Bioengineering, IT);
  
          -  two dynamometric platforms (AMTI, USA);
  
          -  a baropodometric platform (P-WALK; BTS-Bioengineering, IT).
  
        The variables analyzed will be divided according to the administered tests:
  
          1. maintenance of the orthostatic posture: anteroposterior and mediolateral excursion of
             the center of pressure, speed of displacement of the center of pressure, length of
             postural ball and distribution of plantar pressures;
  
          2. gait: spatio-temporal parameters, kinematics of trunk and joints of lower limbs, ground
             reaction forces, moments and joint powers.
  
        A functional evaluation of the foot will be also performed positioning the patient
        prone/supine on the bed and measuring several joint angles.
  
        The measurement will be supported by a video from which images can be subsequently processed
        to trace and obtain the joint angles.
  
        For the functional evaluation of the hand, the patient will be evaluated with the following
        outcome measures:
  
          1. Algo-functional index of the hand according to Dreiser, which analyzes the ability to
             execute some gestures of daily life;
  
          2. Duruöz index, questionnaire for assessing functional impairment of hand.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in serum concentration of GH and IGF1
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: Serum concentration of GH and IGF1
  measure: Change in postural
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: The postural evaluation was performed for 60 seconds while the participants were standing on a baropodometric platform (P-Walk, BTSBioengineering, Italy). They were instructed to maintain an upright position, with their eyes focused on a 6 cm black circle placed at their individual eye level, at a distance of 1.5 meters. Subsequently, they were asked to repeat the same task with their eyes closed. To avoid any learning or fatigue effects, two evaluations were acquired with open eyes and two with closed eyes, and between each trial, the subjects were allowed to rest and sit for 2 minutes, maintaining the foot position during the tests.
  Postural parameters were calculated using dedicated software (G-Studio, BTS, Italy). The relative range of the center of pressure track length is essentially the difference between the maximum and minimum CoP position in the anterior-posterior and medial-lateral (ML) directions during the maintenance of the upright posture.
  measure: Gait analysis
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: All participants were evaluated with 3D-Gait Analysis using an optoelectronic system composed of eight cameras (SMARTDX, BTSBioengineering, Italy) set at 100 Hz, and two force platforms (AMTI, USA). To evaluate the kinematics of each body segment, passive markers were positioned on the participants' body, as described by Davis III et al., and the underlying skeletal model was scaled on behalf of anthropometric data (height, weight, tibial length, distance between the femoral condyles or diameter of the knee, distance between the malleoli or diameter of the ankle, distance between the anterior iliac spines and thickness of the pelvis).
  After placing the markers, the participants were asked to walk barefoot at self-selected speed along a walkway where the force platforms were embedded. Kinematic and kinetic data were collected for each individual from at least five trials to guarantee the reproducibility of the results.
  measure: Change in function of the foot - angle ankle joint
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the ankle joint
  measure: Change in function of the foot - angle subtalar joint
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the subtalar joint
  measure: Change in function of the foot - angle metatarsophalangeal joint of the big toe
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the metatarsophalangeal joint of the big toe
  measure: Change in Function of the hand - Dreiser functional index
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: Algo-functional index of the hand according to Dreiser functional index
  measure: Change in Function of the hand - Duruöz hand index
  time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
  description: Algo-functional index of the hand according to Duruöz hand index
  arm group label: Population # 1
  description: De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old
  arm group label: Population # 2
  description: Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old
  intervention type: Procedure
  intervention name: Medical surgery therapy
  description: De novo patients with acromegaly will undergo medical/surgical therapy of this disease, according to the guidelines of the Endocrine Society. In this population (group #1) morpho-functional examinations together with the evaluation of the stage of the disease, with serum dosage of GH and IGF-1, will be performed at baseline and at months 3, 6 and 12 after initiating the treatment.
  arm group label: Population # 1
  serum dosage of GH and IGF-1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Giovanni Vitale
  role: Principal Investigator
  affiliation: Istituto Auxologico Italiano IRCCS
  last name: Sara Farina, Doctor
  phone: +393386822298
  email: sara.farina@unimi.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Acromegaly