<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/NCT04416503</url>
  </required_header>
  <id_info>
    <org_study_id>AIBU-HSF-SCC-01</org_study_id>
    <nct_id>NCT04416503</nct_id>
  </id_info>
  <brief_title>Effect of Reflexology on Diabetic Foot and Glycemic Control in Elderly Diabetic Individuals</brief_title>
  <official_title>Effect of Reflexology on Ankle Brachial Index, Diabetic Peripheral Neuropathy, and Glycemic Control in Elderly Diabetic Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abant Izzet Baysal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Scientific and Technological Research Council of Turkey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abant Izzet Baysal University</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>
      Background: Glycemic control can be difficult in the elderly with diabetes.Diabetic foot&#xD;
      problems characterized by vascular and neuropathy are serious complications. The&#xD;
      effectiveness of reflexology has been demonstrated to achieve glycemic control and manage&#xD;
      diabetic foot problems.&#xD;
&#xD;
      Objectives: To determine the effect of foot reflexology on ankle brachial index (ABI),&#xD;
      diabetic peripheral neuropathy (DPN) and glycemic control in elderly diabetic individuals.&#xD;
&#xD;
      Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey.&#xD;
      Participants: 48 individuals aged 65 and over enrolled in the elderly health center were&#xD;
      included.&#xD;
&#xD;
      Methods: The elderly were randomized into two groups (study, n=24; control,n=24). Foot&#xD;
      reflexology was performed for 12 week in the study group, whereas the control group continued&#xD;
      their routine treatment and follow-up. Both groups underwent a comprehensive foot examination&#xD;
      for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, glycemic control&#xD;
      (glycated hemoglobin-HbA1c) was evaluated. An independent two-sample t-test was performed for&#xD;
      pre- and post-test between-group comparisons; an effect size analysis was performed to&#xD;
      determine the effect of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Elderly individuals often refer to the health facility with the complications of&#xD;
      diabetes as the first reason. Glycemic control can be quite difficult in elderly diabetic&#xD;
      individuals compared to other age groups. Diabetic foot problems, leading to progressive&#xD;
      problems from circulatory disorders and nervous loss to organ loss, constitute the most&#xD;
      serious complications. Foot reflexology has been shown as a useful practice in the management&#xD;
      of glycemic control and foot problems in diabetic individuals. Reflexology has been shown to&#xD;
      have a positive effect on glycemic control and the management of diabetic foot problems.&#xD;
      There are clinical trials of reflexology in Turkey for use in a variety of diseases or&#xD;
      conditions, but there are no studies about diabetes or diabetes complications. Therefore,&#xD;
      current research is a first in this regard. In this context, this study has been performed to&#xD;
      determine the effect of foot reflexology on ABI, DPN, and glycemic control in elderly&#xD;
      diabetic individuals.&#xD;
&#xD;
      Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey.&#xD;
      Participants: 48 individuals aged 65 and over enrolled in the elderly health center were&#xD;
      included.&#xD;
&#xD;
      Measures: At baseline, subjective area was collected by participant information form.&#xD;
      Glycemic control was evaluated with HbA1c. DPN and ABI assessment were performed by physical&#xD;
      examination of the foot at baseline and three months later.&#xD;
&#xD;
      Methods: The elderly were randomized into two groups (study, n=24; control, n=24). Foot&#xD;
      reflexology was performed for 12 week in the study group, whereas the control group continued&#xD;
      their routine treatment and follow-up. Both groups underwent a comprehensive foot examination&#xD;
      for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, HbA1c was evaluated.&#xD;
      An independent two-sample t-test was performed for pre- and post-test between-group&#xD;
      comparisons; an effect size analysis was performed to determine the effect of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Means of Ankle Brachial Index score</measure>
    <time_frame>3-month change</time_frame>
    <description>Vascular assessment test to assess peripheral circulation in the lower limbs. The measurement, obtained by dividing the highest ankle arterial pressure (posterior tibial or dorsalis pedis) on the same side by brachial pressure, was evaluated using a 5-10-MHz handheld Doppler device and a blood pressure cuff.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Means of Diabetic peripheral neuropathy score</measure>
    <time_frame>3-month change</time_frame>
    <description>Measurement parameter testing whether there is nerve damage due to diabetes by physical examination of the foot. The examination was determined using symptom and disability scores. Symptom scores included questions related to complaints experienced by patients, the location of the complaints, the presence of night or day symptoms, and how the symptoms relieved/subsided. Disability scores were determined with four parameters: vibration sensation (128 Hz tuning fork), pinprick sensation, achilles reflex and sensitivity to touch (Semmes-Weinstein nylon monofilaments 10 g).Participant responses and examination findings were scored according to a guideline and a neuropathy score was obtained for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1c levels (%)</measure>
    <time_frame>3-month change</time_frame>
    <description>Blood test to evaluate glycemic control. Blood sample was collected in EDTA-coated tubes (2 mL of whole) from the participants.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Reflexology</condition>
  <condition>Type 2 Diabetes</condition>
  <condition>Older People</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Foot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual follow-up was done to the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Foot reflexology</intervention_name>
    <description>Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 65 years with type 2 diabetes&#xD;
&#xD;
          -  No fractures or open wounds on both lower limbs&#xD;
&#xD;
          -  No single or double sided amputation on the lower limbs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled high blood pressure&#xD;
&#xD;
          -  Acute infection with fever&#xD;
&#xD;
          -  Acute surgical conditions&#xD;
&#xD;
          -  Receiving dialysis treatment&#xD;
&#xD;
          -  Being a verbal communication problem related to Alzheimer's or dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Süleyman ÖZSARI, PhD, DR</last_name>
    <role>Study Director</role>
    <affiliation>Bolu Provincial Health Directorate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bolu Elderly Health Center</name>
      <address>
        <city>Bolu</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Ankle brachial index</keyword>
  <keyword>Diabetic neuropathies</keyword>
  <keyword>Glycated hemoglobin A</keyword>
  <keyword>Musculoskeletal manipulations</keyword>
  <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/NCT04416503
org study id: AIBU-HSF-SCC-01
nct id: NCT04416503
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Glycemic control can be difficult in the elderly with diabetes.Diabetic foot
      problems characterized by vascular and neuropathy are serious complications. The
      effectiveness of reflexology has been demonstrated to achieve glycemic control and manage
      diabetic foot problems.

      Objectives: To determine the effect of foot reflexology on ankle brachial index (ABI),
      diabetic peripheral neuropathy (DPN) and glycemic control in elderly diabetic individuals.

      Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey.
      Participants: 48 individuals aged 65 and over enrolled in the elderly health center were
      included.

      Methods: The elderly were randomized into two groups (study, n=24; control,n=24). Foot
      reflexology was performed for 12 week in the study group, whereas the control group continued
      their routine treatment and follow-up. Both groups underwent a comprehensive foot examination
      for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, glycemic control
      (glycated hemoglobin-HbA1c) was evaluated. An independent two-sample t-test was performed for
      pre- and post-test between-group comparisons; an effect size analysis was performed to
      determine the effect of intervention.
Background: Elderly individuals often refer to the health facility with the complications of
      diabetes as the first reason. Glycemic control can be quite difficult in elderly diabetic
      individuals compared to other age groups. Diabetic foot problems, leading to progressive
      problems from circulatory disorders and nervous loss to organ loss, constitute the most
      serious complications. Foot reflexology has been shown as a useful practice in the management
      of glycemic control and foot problems in diabetic individuals. Reflexology has been shown to
      have a positive effect on glycemic control and the management of diabetic foot problems.
      There are clinical trials of reflexology in Turkey for use in a variety of diseases or
      conditions, but there are no studies about diabetes or diabetes complications. Therefore,
      current research is a first in this regard. In this context, this study has been performed to
      determine the effect of foot reflexology on ABI, DPN, and glycemic control in elderly
      diabetic individuals.

      Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey.
      Participants: 48 individuals aged 65 and over enrolled in the elderly health center were
      included.

      Measures: At baseline, subjective area was collected by participant information form.
      Glycemic control was evaluated with HbA1c. DPN and ABI assessment were performed by physical
      examination of the foot at baseline and three months later.

      Methods: The elderly were randomized into two groups (study, n=24; control, n=24). Foot
      reflexology was performed for 12 week in the study group, whereas the control group continued
      their routine treatment and follow-up. Both groups underwent a comprehensive foot examination
      for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, HbA1c was evaluated.
      An independent two-sample t-test was performed for pre- and post-test between-group
      comparisons; an effect size analysis was performed to determine the effect of intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Supportive Care
masking: Single (Participant)
measure: Means of Ankle Brachial Index score
time frame: 3-month change
description: Vascular assessment test to assess peripheral circulation in the lower limbs. The measurement, obtained by dividing the highest ankle arterial pressure (posterior tibial or dorsalis pedis) on the same side by brachial pressure, was evaluated using a 5-10-MHz handheld Doppler device and a blood pressure cuff.
measure: Means of Diabetic peripheral neuropathy score
time frame: 3-month change
description: Measurement parameter testing whether there is nerve damage due to diabetes by physical examination of the foot. The examination was determined using symptom and disability scores. Symptom scores included questions related to complaints experienced by patients, the location of the complaints, the presence of night or day symptoms, and how the symptoms relieved/subsided. Disability scores were determined with four parameters: vibration sensation (128 Hz tuning fork), pinprick sensation, achilles reflex and sensitivity to touch (Semmes-Weinstein nylon monofilaments 10 g).Participant responses and examination findings were scored according to a guideline and a neuropathy score was obtained for each participant.
measure: HbA1c levels (%)
time frame: 3-month change
description: Blood test to evaluate glycemic control. Blood sample was collected in EDTA-coated tubes (2 mL of whole) from the participants.
arm group label: Intervention group
arm group type: Experimental
description: Foot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up.
arm group label: Control group
arm group type: No Intervention
description: Usual follow-up was done to the control group.
intervention type: Other
intervention name: Foot reflexology
description: Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Süleyman ÖZSARI, PhD, DR
role: Study Director
affiliation: Bolu Provincial Health Directorate
facility: 
country: Turkey
responsible party type: Sponsor
sharing ipd: No