<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/NCT03038490</url>
  </required_header>
  <id_info>
    <org_study_id>KW/FR-16-167(104-04)</org_study_id>
    <nct_id>NCT03038490</nct_id>
  </id_info>
  <brief_title>The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers</brief_title>
  <official_title>The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for the Treatment of Pressure Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Our Lady of Maryknoll Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wong Tai Sin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Our Lady of Maryknoll Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and&#xD;
      HMB for a maximum period of four weeks is more beneficial than the standard dietary approach&#xD;
      to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions&#xD;
      and length of hospitalizations for these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients would be assessed by a dietitian to ensure them receiving nutritional support of&#xD;
      at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method.&#xD;
      During the study period, vitamin C and zinc supplement would not be given. Nutritional&#xD;
      supplement other than that provided by the dietitian to meet the energy and protein&#xD;
      requirement would not be given. The pressure ulcers would be cared according to the &quot;Basic&#xD;
      nursing standards for patient care: Wound dressing - Version 5&quot; published by the Hospital&#xD;
      Authority Head Office.&#xD;
&#xD;
      The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB&#xD;
      (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</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>percentage change in pressure ulcer area</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Pressure Ulcer Scale for Healing (PUSH)</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of hospital admissions</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospitalisation</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Pressure Ulcers Stage III</condition>
  <condition>Pressure Ulcer, Stage IV</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment group would be given 2 Sackets of an oral mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ABOUND</intervention_name>
    <description>an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inpatients of medical and geriatric wards of OLMH and WTSH&#xD;
&#xD;
          2. Aged 18 and older with stage III - IV lesions&#xD;
&#xD;
          3. Patients fed orally or through feeding tubes were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with history of using the nutritional supplement (ABOUND) in previous three&#xD;
             months&#xD;
&#xD;
          2. Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis&#xD;
&#xD;
          3. Patients requiring protein restriction&#xD;
&#xD;
          4. Patients with poorly controlled diabetes mellitus (latest HbA1C &gt; 8.5) (healing&#xD;
             process may be affected&#xD;
&#xD;
          5. Patients under palliative care&#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_contact>
    <last_name>Kwok Man Lo, FHKAM (Med)</last_name>
    <email>lokm1@ha.org.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ka Ying Doris Miu, FHKAM (Med)</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Our Lady of Maryknoll Hospital</name>
      <address>
        <city>Wong Tai Sin</city>
        <zip>852</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.</citation>
    <PMID>19563522</PMID>
  </reference>
  <reference>
    <citation>Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.</citation>
    <PMID>24810310</PMID>
  </reference>
  <reference>
    <citation>Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. Erratum In: Ann Intern Med. 2015 Dec 15;163(12):964.</citation>
    <PMID>25643304</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Our Lady of Maryknoll Hospital</investigator_affiliation>
    <investigator_full_name>Lo Kwok Man</investigator_full_name>
    <investigator_title>Associate Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03038490
org study id: KW/FR-16-167(104-04)
nct id: NCT03038490
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and
      HMB for a maximum period of four weeks is more beneficial than the standard dietary approach
      to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions
      and length of hospitalizations for these patients.
All patients would be assessed by a dietitian to ensure them receiving nutritional support of
      at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method.
      During the study period, vitamin C and zinc supplement would not be given. Nutritional
      supplement other than that provided by the dietitian to meet the energy and protein
      requirement would not be given. The pressure ulcers would be cared according to the "Basic
      nursing standards for patient care: Wound dressing - Version 5" published by the Hospital
      Authority Head Office.

      The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB
      (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: percentage change in pressure ulcer area
time frame: 4 weeks
measure: change in Pressure Ulcer Scale for Healing (PUSH)
time frame: 4 weeks
measure: number of hospital admissions
time frame: six months
measure: length of hospitalisation
time frame: six months
arm group label: Study group
arm group type: Experimental
description: The treatment group would be given 2 Sackets of an oral mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.
arm group label: Control group
arm group type: No Intervention
description: All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given.
intervention type: Dietary Supplement
intervention name: ABOUND
description: an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kwok Man Lo, FHKAM (Med)
email: lokm1@ha.org.hk
last name: Ka Ying Doris Miu, FHKAM (Med)
facility: 
status: Recruiting
country: Hong Kong
citation: Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.
PMID: 19563522
citation: Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.
PMID: 24810310
citation: Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. Erratum In: Ann Intern Med. 2015 Dec 15;163(12):964.
PMID: 25643304
responsible party type: Principal Investigator
investigator affiliation: Our Lady of Maryknoll Hospital
investigator full name: Lo Kwok Man
investigator title: Associate Consultant
mesh term: Pressure Ulcer
mesh term: Ulcer
sharing ipd: No