<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/NCT02235935</url>
  </required_header>
  <id_info>
    <org_study_id>112/14</org_study_id>
    <nct_id>NCT02235935</nct_id>
  </id_info>
  <brief_title>The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy</brief_title>
  <official_title>The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non&#xD;
      proliferative DR and proliferative DR. The damage is caused by either macular edema, macular&#xD;
      ischemia that can be followed by vascular proliferation.&#xD;
&#xD;
      Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in&#xD;
      the tissues and has been proven to be beneficial in treating different wounds in diabetic&#xD;
      patients but its effect hasn't been tested in diabetic retinopathy yet.&#xD;
&#xD;
      This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due&#xD;
      to different indications such as chronic wounds or radiation damages and who also have&#xD;
      diabetic retinopathy. These patients will undergo opthalmic physical examination including&#xD;
      fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography).&#xD;
      Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe&#xD;
      Medical Center for all diabetic patients prior to their first treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>OCT results</measure>
    <time_frame>1 month</time_frame>
    <description>the reduction in retina width as recorded on OCT following 20 treatments in Hyperbaric Chamber</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>1 month</time_frame>
    <description>changes in visual acuity as recorded in ophthalmologic exam before and after treatments in hyperbaric chamber</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>diabetic patients, hyperbaric chamber, diabetic retinopathy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any diabetic patient undergoing hyperbaric chamber treatment due to diabetic ulcers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          1. Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who&#xD;
             are scheduled for hyperbaric treatment for other indications than DR.&#xD;
&#xD;
          2. Patients who signed an informed consent form and agree to undergo an ophthalmic&#xD;
             physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT&#xD;
             exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric&#xD;
             treatments will be conducted according to the main indication for which they have been&#xD;
             assigned this treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with Carotid stenosis of more than 70%&#xD;
&#xD;
          2. Anemia of &lt; 10mg/Dl&#xD;
&#xD;
          3. Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber&#xD;
             treatment.&#xD;
&#xD;
          4. Patients with claustrophobia or that cannot decompress properly.&#xD;
&#xD;
          5. Patients with any malignant disease&#xD;
&#xD;
          6. Patients with inability to sign informed consent&#xD;
&#xD;
        Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen.&#xD;
&#xD;
        -&#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_official>
    <last_name>Shai Efrati</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf Harofe MC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assaf Harofe Medical Center</name>
      <address>
        <city>Zerifin</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rubinstein, MD</last_name>
      <phone>0097289779358</phone>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</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>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</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/NCT02235935
org study id: 112/14
nct id: NCT02235935
lead sponsor: 
has dmc: No
Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non
      proliferative DR and proliferative DR. The damage is caused by either macular edema, macular
      ischemia that can be followed by vascular proliferation.

      Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in
      the tissues and has been proven to be beneficial in treating different wounds in diabetic
      patients but its effect hasn't been tested in diabetic retinopathy yet.

      This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due
      to different indications such as chronic wounds or radiation damages and who also have
      diabetic retinopathy. These patients will undergo opthalmic physical examination including
      fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography).
      Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe
      Medical Center for all diabetic patients prior to their first treatment.
observational model: Cohort
time perspective: Prospective
measure: OCT results
time frame: 1 month
description: the reduction in retina width as recorded on OCT following 20 treatments in Hyperbaric Chamber
measure: Visual Acuity
time frame: 1 month
description: changes in visual acuity as recorded in ophthalmologic exam before and after treatments in hyperbaric chamber
arm group label: diabetic patients, hyperbaric chamber, diabetic retinopathy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shai Efrati
role: Principal Investigator
affiliation: Assaf Harofe MC
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy