<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/NCT01731808</url>
  </required_header>
  <id_info>
    <org_study_id>2010-0278/0</org_study_id>
    <nct_id>NCT01731808</nct_id>
  </id_info>
  <brief_title>Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study</brief_title>
  <official_title>Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zurich University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luzerner Kantonsspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kantonsspital Frauenfeld</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spital Zollikerberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zurich University of Applied Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the feasibility and effectiveness of a physician&#xD;
      directed nurse managed earlier outpatient counselling intervention for patients with diabetic&#xD;
      foot ulceration.&#xD;
&#xD;
      For the purpose effectiveness is defined in two ways.1) as a reduction in hospital&#xD;
      readmissions for complication for foot ulcers such as amputation or increased severity of the&#xD;
      ulcer and 2) reduction in amputations, readmission rates. Selected covariates&#xD;
      (self-efficacy,self-management, social support and depression) will be included to estimate&#xD;
      predictors for readmission and amputation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased&#xD;
      peripheral circulation impaired sensation leading to the development of foot ulcers that lead&#xD;
      to amputations of toes, feet and limbs. These complications not only have devastating effects&#xD;
      on the individual in terms of loss of functionality but also impact the patient's ability to&#xD;
      carry out and enjoy occupational, recreational and family functioning activities.&#xD;
      Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and&#xD;
      loss of productivity. All of these have personal as well as societal economical implications.&#xD;
&#xD;
      Currently, the standard of care includes admissions to the hospital lasting up to six weeks&#xD;
      for medical observations and treatment of food ulcers.&#xD;
&#xD;
      The nursing responsibilities include daily or more frequent wound care as well as education&#xD;
      counselling and skill building for diabetes self-management; therefore, an alternative to&#xD;
      current practices must be considered. Such an alternative strategy has the potential benefit&#xD;
      for the patient as well as the societal benefit of economic savings should such an outpatient&#xD;
      nurse managed intervention be as or more effective as current practice. This type of service&#xD;
      would allow the patients to remain in their home for care with probably a reduced risk for&#xD;
      nosocomial infections.&#xD;
&#xD;
      This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional&#xD;
      patient education program to current management of foot care in patients with DM. We plan to&#xD;
      determine whether foot ulcer care in hospital under medical and nursing management can be&#xD;
      improved by early discharge of the Intervention group (IG) to the well established outpatient&#xD;
      wound care combined with an additional new outpatient nurse managed counselling program.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      This study aims to test an alternative to current standard of care for patients with foot&#xD;
      ulcers. A RCT is the preferred method to establish efficacy for this alternative nurse&#xD;
      managed intervention; and if found to be effective, the current study will also allow an&#xD;
      evaluation of the cost effectiveness of this intervention and the potential economic&#xD;
      reduction in cost to the health care system.&#xD;
&#xD;
      Also, patients in the hospital are in danger of acquiring nosocomial infections, are subject&#xD;
      to medical and nursing errors and are potentially accident prone; all of this together with a&#xD;
      general preference for being able to live at home as compared to the hospital, together with&#xD;
      the cost savings mentioned above could have a considerable impact on patient's quality of&#xD;
      life, satisfaction with care, improvement in food ulcer and amputation outcomes.&#xD;
&#xD;
      Significance:&#xD;
&#xD;
      The potential implications are major in terms of quality of life, reduction in morbidity in&#xD;
      disability days, and cost savings. It is anticipated that this intervention is at least as&#xD;
      effective as hospital stay, and being surrounded by their own loved ones without the threats&#xD;
      that a hospital setting presents. The findings will be important to consider whether clinical&#xD;
      practice can be changed to benefit patients. If the study results show that the subjects in&#xD;
      the IG have better skills in monitoring and treating their diabetic foot ulcerations and&#xD;
      eventually avoid developing further complications the intervention can be applied to future&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>feasibility of an intensive nurse led education program</measure>
    <time_frame>The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.</time_frame>
    <description>Recruitment procedures feasible yes/no; Randomization procedure feasible yes/no; Timeframe of the five week educational program feasible yes/no; Intervention material suitable yes/no</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants received three specially-developed brochures with information regarding the diabetic foot condition. The brochures contained explanations to a) the cause and warning signs of diabetic foot ulcers, b) the precautions patients can take in their daily life, and c) helpful foot gymnastics to be practiced at home. The participants who were randomized in the control group received standard care. Standard care consisted of either physician-prescribed inpatient or outpatient wound care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nursing counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nursing counseling</intervention_name>
    <description>The participants who were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received a foot care kit with essential foot care material and a foot care diary.</description>
    <arm_group_label>Nursing counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients age 18 or older with&#xD;
&#xD;
          -  current treatment for ulceration and/or amputation of a lower limb&#xD;
&#xD;
          -  stable wound healing&#xD;
&#xD;
          -  no signs of wound infection&#xD;
&#xD;
          -  stable diabetes&#xD;
&#xD;
          -  manageable pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with cognitive impairment and psychiatric diseases&#xD;
&#xD;
          -  patients living in dependent living facilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kantonsspital Frauenfeld</name>
      <address>
        <city>Frauenfeld</city>
        <zip>8501</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luzerner Kantonsspital</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Winterthur</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spital Zollikerberg</name>
      <address>
        <city>Zollikerberg</city>
        <zip>8125</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Balgrist</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>March 3, 2014</last_update_submitted>
  <last_update_submitted_qc>March 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zurich University of Applied Sciences</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Lorenz Imhof</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Nursing counseling</keyword>
  <keyword>diabetic 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>
  <!-- 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/NCT01731808
org study id: 2010-0278/0
nct id: NCT01731808
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to evaluate the feasibility and effectiveness of a physician
      directed nurse managed earlier outpatient counselling intervention for patients with diabetic
      foot ulceration.

      For the purpose effectiveness is defined in two ways.1) as a reduction in hospital
      readmissions for complication for foot ulcers such as amputation or increased severity of the
      ulcer and 2) reduction in amputations, readmission rates. Selected covariates
      (self-efficacy,self-management, social support and depression) will be included to estimate
      predictors for readmission and amputation.
Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased
      peripheral circulation impaired sensation leading to the development of foot ulcers that lead
      to amputations of toes, feet and limbs. These complications not only have devastating effects
      on the individual in terms of loss of functionality but also impact the patient's ability to
      carry out and enjoy occupational, recreational and family functioning activities.
      Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and
      loss of productivity. All of these have personal as well as societal economical implications.

      Currently, the standard of care includes admissions to the hospital lasting up to six weeks
      for medical observations and treatment of food ulcers.

      The nursing responsibilities include daily or more frequent wound care as well as education
      counselling and skill building for diabetes self-management; therefore, an alternative to
      current practices must be considered. Such an alternative strategy has the potential benefit
      for the patient as well as the societal benefit of economic savings should such an outpatient
      nurse managed intervention be as or more effective as current practice. This type of service
      would allow the patients to remain in their home for care with probably a reduced risk for
      nosocomial infections.

      This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional
      patient education program to current management of foot care in patients with DM. We plan to
      determine whether foot ulcer care in hospital under medical and nursing management can be
      improved by early discharge of the Intervention group (IG) to the well established outpatient
      wound care combined with an additional new outpatient nurse managed counselling program.

      Expected results:

      This study aims to test an alternative to current standard of care for patients with foot
      ulcers. A RCT is the preferred method to establish efficacy for this alternative nurse
      managed intervention; and if found to be effective, the current study will also allow an
      evaluation of the cost effectiveness of this intervention and the potential economic
      reduction in cost to the health care system.

      Also, patients in the hospital are in danger of acquiring nosocomial infections, are subject
      to medical and nursing errors and are potentially accident prone; all of this together with a
      general preference for being able to live at home as compared to the hospital, together with
      the cost savings mentioned above could have a considerable impact on patient's quality of
      life, satisfaction with care, improvement in food ulcer and amputation outcomes.

      Significance:

      The potential implications are major in terms of quality of life, reduction in morbidity in
      disability days, and cost savings. It is anticipated that this intervention is at least as
      effective as hospital stay, and being surrounded by their own loved ones without the threats
      that a hospital setting presents. The findings will be important to consider whether clinical
      practice can be changed to benefit patients. If the study results show that the subjects in
      the IG have better skills in monitoring and treating their diabetic foot ulcerations and
      eventually avoid developing further complications the intervention can be applied to future
      patients.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: feasibility of an intensive nurse led education program
time frame: The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.
description: Recruitment procedures feasible yes/no; Randomization procedure feasible yes/no; Timeframe of the five week educational program feasible yes/no; Intervention material suitable yes/no
arm group label: Standard care
arm group type: No Intervention
description: All participants received three specially-developed brochures with information regarding the diabetic foot condition. The brochures contained explanations to a) the cause and warning signs of diabetic foot ulcers, b) the precautions patients can take in their daily life, and c) helpful foot gymnastics to be practiced at home. The participants who were randomized in the control group received standard care. Standard care consisted of either physician-prescribed inpatient or outpatient wound care.
arm group label: Nursing counseling
arm group type: Experimental
intervention type: Behavioral
intervention name: Nursing counseling
description: The participants who were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received a foot care kit with essential foot care material and a foot care diary.
arm group label: Nursing counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Zurich University of Applied Sciences
investigator full name: Prof. Dr. Lorenz Imhof
investigator title: Prof. Dr.
mesh term: Diabetic Foot
mesh term: Foot Ulcer