<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/NCT01680809</url>
  </required_header>
  <id_info>
    <org_study_id>CWCT-001</org_study_id>
    <nct_id>NCT01680809</nct_id>
  </id_info>
  <brief_title>Compliance of Compression Therapy in Healed Venous Ulcerations</brief_title>
  <official_title>Compliance of Compression Therapy in Healed Venous Ulcerations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to determine if compliance with compression therapy is increased in patients&#xD;
      with healed venous insufficiency ulcerations when lower levels of compression therapy are&#xD;
      prescribed. This study will measure compliance with compression therapy at low levels of&#xD;
      compression. It will also seek to determine if compression therapy aids in the prevention of&#xD;
      venous insufficiency ulcer recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study looks to determine if patients with a history of venous insufficiency and recently&#xD;
      healed venous insufficiency ulcerations are compliant with lower levels of compression&#xD;
      therapy. It also seeks to evaluate the efficacy of compression therapy in the prevention of&#xD;
      recurrence of venous insufficiency ulcerations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study never started&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance of Compression Therapy</measure>
    <time_frame>12 months</time_frame>
    <description>Patients will be assessed for compliance of compression therapy at the following intervals (1 month, 3 months, 6 months, 9 months, and 12 months) -- this will be accomplished via patient questionnaire/interview at scheduled appointments at each stated interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ulceration recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>We will evaluate if venous ulcerations have recurred with compression therapy over the course of 12 months. The patient will be seen/evaluated at appointments scheduled at 1 month, 3 months, 6 months, 9 months and 12 months. At each visit, the patient will be evaluated for recurrence of ulcerations. If ulceration recurs, then the patient will be removed from the study and be eligible for treatment of ulcerations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>Compression stocking 15-20mmHg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compression stocking 15-20mmHg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compression stocking 20-30mmHg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compression stocking 20-30mmHg</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compression stocking 15-20mmHg</intervention_name>
    <description>Compression stocking with 15-20mmHg of compression</description>
    <arm_group_label>Compression stocking 15-20mmHg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compression stocking 20-30mmHg</intervention_name>
    <description>Compression stocking with 20-30mmHg of compression</description>
    <arm_group_label>Compression stocking 20-30mmHg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recently healed venous insufficiency ulcerations&#xD;
&#xD;
          -  History of venous insufficiency&#xD;
&#xD;
          -  Patient from UH Richmond Wound Care Center (recently discharged/healed venous&#xD;
             ulcerations)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Patients with diagnosed arterial insufficiency or ABI less than 0.5&#xD;
&#xD;
          -  Patients that are diagnosed with Congestive Heart Failure and not cardiac cleared&#xD;
&#xD;
          -  Patients with paralysis or incapacitated physically or mentally (due to inability to&#xD;
             apply compression stockings)&#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>Nicole E Allen-Wilson, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Richmond Medical Center (University Hospitals of Cleveland)</name>
      <address>
        <city>Richmond Heights</city>
        <state>Ohio</state>
        <zip>44143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Milic DJ, Zivic SS, Bogdanovic DC, Karanovic ND, Golubovic ZV. Risk factors related to the failure of venous leg ulcers to heal with compression treatment. J Vasc Surg. 2009 May;49(5):1242-7. doi: 10.1016/j.jvs.2008.11.069. Epub 2009 Feb 23.</citation>
    <PMID>19233601</PMID>
  </reference>
  <reference>
    <citation>Gillespie DL; Writing Group III of the Pacific Vascular Symposium 6; Kistner B, Glass C, Bailey B, Chopra A, Ennis B, Marston B, Masuda E, Moneta G, Nelzen O, Raffetto J, Raju S, Vedantham S, Wright D, Falanga V. Venous ulcer diagnosis, treatment, and prevention of recurrences. J Vasc Surg. 2010 Nov;52(5 Suppl):8S-14S. doi: 10.1016/j.jvs.2010.05.068. Epub 2010 Aug 3. No abstract available.</citation>
    <PMID>20678885</PMID>
  </reference>
  <reference>
    <citation>Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999 Sep;30(3):491-8. doi: 10.1016/s0741-5214(99)70076-5.</citation>
    <PMID>10477642</PMID>
  </reference>
  <reference>
    <citation>Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.</citation>
    <PMID>17012004</PMID>
  </reference>
  <reference>
    <citation>Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.</citation>
    <PMID>15183623</PMID>
  </reference>
  <reference>
    <citation>Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles, 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2011. Print.</citation>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Venous insufficiency</keyword>
  <keyword>Venous stasis ulcerations</keyword>
  <keyword>Compression stockings</keyword>
  <keyword>Compression stocking compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</mesh_term>
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>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/NCT01680809
org study id: CWCT-001
nct id: NCT01680809
lead sponsor: 
has dmc: No
This study seeks to determine if compliance with compression therapy is increased in patients
      with healed venous insufficiency ulcerations when lower levels of compression therapy are
      prescribed. This study will measure compliance with compression therapy at low levels of
      compression. It will also seek to determine if compression therapy aids in the prevention of
      venous insufficiency ulcer recurrence.
This study looks to determine if patients with a history of venous insufficiency and recently
      healed venous insufficiency ulcerations are compliant with lower levels of compression
      therapy. It also seeks to evaluate the efficacy of compression therapy in the prevention of
      recurrence of venous insufficiency ulcerations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Compliance of Compression Therapy
time frame: 12 months
description: Patients will be assessed for compliance of compression therapy at the following intervals (1 month, 3 months, 6 months, 9 months, and 12 months) -- this will be accomplished via patient questionnaire/interview at scheduled appointments at each stated interval.
measure: Ulceration recurrence
time frame: 12 months
description: We will evaluate if venous ulcerations have recurred with compression therapy over the course of 12 months. The patient will be seen/evaluated at appointments scheduled at 1 month, 3 months, 6 months, 9 months and 12 months. At each visit, the patient will be evaluated for recurrence of ulcerations. If ulceration recurs, then the patient will be removed from the study and be eligible for treatment of ulcerations.
arm group label: Compression stocking 15-20mmHg
arm group type: Experimental
description: Compression stocking 15-20mmHg
arm group label: Compression stocking 20-30mmHg
arm group type: Experimental
description: Compression stocking 20-30mmHg
intervention type: Device
intervention name: Compression stocking 15-20mmHg
description: Compression stocking with 15-20mmHg of compression
arm group label: Compression stocking 15-20mmHg
intervention type: Device
intervention name: Compression stocking 20-30mmHg
description: Compression stocking with 20-30mmHg of compression
arm group label: Compression stocking 20-30mmHg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole E Allen-Wilson, DPM
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
citation: Milic DJ, Zivic SS, Bogdanovic DC, Karanovic ND, Golubovic ZV. Risk factors related to the failure of venous leg ulcers to heal with compression treatment. J Vasc Surg. 2009 May;49(5):1242-7. doi: 10.1016/j.jvs.2008.11.069. Epub 2009 Feb 23.
PMID: 19233601
citation: Gillespie DL; Writing Group III of the Pacific Vascular Symposium 6; Kistner B, Glass C, Bailey B, Chopra A, Ennis B, Marston B, Masuda E, Moneta G, Nelzen O, Raffetto J, Raju S, Vedantham S, Wright D, Falanga V. Venous ulcer diagnosis, treatment, and prevention of recurrences. J Vasc Surg. 2010 Nov;52(5 Suppl):8S-14S. doi: 10.1016/j.jvs.2010.05.068. Epub 2010 Aug 3. No abstract available.
PMID: 20678885
citation: Marston WA, Carlin RE, Passman MA, Farber MA, Keagy BA. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. J Vasc Surg. 1999 Sep;30(3):491-8. doi: 10.1016/s0741-5214(99)70076-5.
PMID: 10477642
citation: Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.
PMID: 17012004
citation: Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
PMID: 15183623
citation: Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles, 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2011. Print.
responsible party type: Sponsor
mesh term: Venous Insufficiency
mesh term: Varicose Ulcer
mesh term: Ulcer