<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/NCT03283800</url>
  </required_header>
  <id_info>
    <org_study_id>15/04</org_study_id>
    <nct_id>NCT03283800</nct_id>
  </id_info>
  <brief_title>Copper Impact on Venous Insufficiency and Lipodermatosclerosis</brief_title>
  <acronym>CIVIL</acronym>
  <official_title>Impact of Copper Compression Stockings on Venous Insufficiency and Lipodermatosclerosis: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Croydon Health Services NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Croydon Health Services NHS Trust</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>
      Venous disease has an adverse impact on the quality of life of patients and the NHS spends&#xD;
      considerable resources on this chronic condition. Copper has been shown to promote new blood&#xD;
      vessel formation and therefore improve blood supply to the affected area and possibly skin&#xD;
      conditions. Copper has also been shown to have strong antimicrobial properties. We plan to&#xD;
      perform a study whereby patients who would normally be given leg stockings will be asked to&#xD;
      wear similar stockings except that one of the stockings will contain copper fibers. Neither&#xD;
      the patient nor the clinician will know which is which. Photographs of the leg conditions&#xD;
      will be taken at baseline, 2, 4 and 8 weeks to evaluate healing. Benefit will be evaluated by&#xD;
      a symptom questionnaire, severity scoring tools and healing scores taken from the serial&#xD;
      photographs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised controlled pilot study to assess the feasibility of copper impregnated&#xD;
      stockings. All patients with CEAP classification 4 in both legs and venous disease identified&#xD;
      by venous duplex will be recruited from the vascular clinics within Croydon Health Services&#xD;
      over a period of three months. All patients will be given a patient information sheet&#xD;
      describing the study prior to consent. Patients will be giving adequate time to read the&#xD;
      information. Informed consent and the agreement for photography of their legs will be&#xD;
      obtained. Patients will be assessed at baseline and at 2, 4 and 8 weeks follow-up.&#xD;
&#xD;
      Copper impregnated stockings:&#xD;
&#xD;
      All patients will be asked to wear compression stockings (14-18mmHg). These closed-toe and&#xD;
      below-the-knee stockings are made of 88% nylon, 5% elastin, and 7% spandex and come in&#xD;
      various sizes. One of the pair will have copper oxide ions permanently attached to the nylon&#xD;
      fibres and these stockings will contain 2-3% copper ions. The patients will wear a copper&#xD;
      stocking on one leg (study leg) and a non-copper stocking on the other (control leg). Both&#xD;
      the patients and the clinicians will be blinded to the copper impregnated stocking.&#xD;
&#xD;
      Randomisation:&#xD;
&#xD;
      All stockings are marked with an 'L' for the left or 'R' for the right foot. The manufacturer&#xD;
      has randomly marked the copper stockings with an 'L' or 'R' and paired these with a&#xD;
      non-copper stocking. A closed envelope will contain the unique numbers of all the pairs of&#xD;
      stockings and the information on which sock contains the copper. This envelope will remain&#xD;
      closed for the whole recruitment period.&#xD;
&#xD;
      Patient data, history and physical examination:&#xD;
&#xD;
      Demographic data such as age, ethnicity, height and weight will be collected. Past medical&#xD;
      history such as concomitant (chronic) diseases and the use of medications will be obtained.&#xD;
      At each visit, subjective symptoms will be obtained using the Aberdeen Varicose Veins&#xD;
      Questionnaire (AVVQ). For obtaining objective signs, the CEAP classification and the Venous&#xD;
      Clinical Severity Scoring (VCSS) will be performed for grading the severity of the venous&#xD;
      insufficiency per leg individually, and photographs with the Eykona® 3D camera will be taken.&#xD;
      All data sets will be coded and anonymised. The data will be stored in a secure room within&#xD;
      the Trust. All electronic data will be stored within password protected IT system within the&#xD;
      Trust, which is only accessible by the clinical and research team.&#xD;
&#xD;
      Eykona® Wound Measurement System:&#xD;
&#xD;
      Skin changes associated with lipodermatosclerosis such as erythema, induration,&#xD;
      hyperpigmentation and white atrophy, will be measured using the Eykona® Wound Measuring&#xD;
      System (Type EYK10001). This system contains a 3D portable camera with software that enables&#xD;
      precise measurements of wound size and tissue condition. Photographs will be taken at each&#xD;
      visit. The surface area of the skin changes will be calculated.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Statistical analysis will be performed using SPSS version 20.0 or higher. The CEAP&#xD;
      classification, the Venous Clinical Severity Score and the AVVQ score at the 2, 4, and 8&#xD;
      weeks assessment will be compared with the baseline scores. The length, width and surface&#xD;
      area of the skin condition from the leg with the copper will be compared with the control leg&#xD;
      and the measurements at the 2, 4, and 8 weeks assessment will be compared with the baseline&#xD;
      measurements. Paired t-test will be used for continuous data at baseline and a multilevel&#xD;
      (mixed) regression model will be used to analyse the change over time.&#xD;
&#xD;
      Sample size calculation:&#xD;
&#xD;
      The sample size for this study will be 15. This number is based on the prevalence of the&#xD;
      disease in this hospital over three months' time. There is no existing data available to&#xD;
      allow a sample size calculation. The data collection of this pilot study will enable power&#xD;
      calculation for a larger multicentre study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2015</start_date>
  <completion_date type="Actual">January 9, 2017</completion_date>
  <primary_completion_date type="Actual">January 9, 2017</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>All participants will be asked to wear compression stockings. One of the pair will have copper oxide ions permanently attached to the nylon fibres and these stockings will contain 2-3% copper ions. The participants will wear a copper stocking on one leg (study leg) and a non-copper stocking on the other (control leg).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>All stockings are marked with an 'L' for the left or 'R' for the right foot. The manufacturer has randomly marked the copper stockings with an 'L' or 'R' and paired these with a non-copper stocking. A closed envelope will contain the unique numbers of all the pairs of stockings and the information on which stocking contains the copper. This envelope will remain closed for the whole recruitment period and throughout analysis of the results.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Aberdeen Varicose Vein Questionnaire (AVVQ)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Validated questionnaire consisting of 13 questions on signs and symptoms of chronic venous insufficiency for each leg seperately and questions on compression stocking usage and quality of life. The scoring of the questionnaire is from 0, which indicates no effect on the patient, to 100, which indicates a severe effect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Venous Clinical Severity Scoring (VCSS)</measure>
    <time_frame>24 hours</time_frame>
    <description>Assessment tool consisting of 10 items: pain, varicose veins, oedema, skin pigmentation, inflammation, induration, ulceration (number, size and duration) and use of compression therapy, which are scored on a severity scale from 0 to 3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipodermatosclerosis surface area</measure>
    <time_frame>2, 4 and 8 weeks after wearing compression stockings</time_frame>
    <description>Surface area of the affected skin measured using 3D photographs with the Eykona® Wound Measuring System (Type EYK10001).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Lipodermatosclerosis</condition>
  <condition>Chronic Venous Insufficiency</condition>
  <condition>Venous Insufficiency</condition>
  <condition>Varicose Veins</condition>
  <arm_group>
    <arm_group_label>Copper impregnated compression stocking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal compression stocking</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Copper impregnated compression stocking</intervention_name>
    <description>Copper impregnated compression stocking</description>
    <arm_group_label>Copper impregnated compression stocking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal compression stocking</intervention_name>
    <description>Normal compression stocking without copper</description>
    <arm_group_label>Normal compression stocking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients&#xD;
&#xD;
          -  CEAP classification 4 in both legs&#xD;
&#xD;
          -  Venous disease confirmed by venous duplex&#xD;
&#xD;
          -  Ability to understand and read the patient information sheet (in English)&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current ulceration&#xD;
&#xD;
          -  Wilson's disease&#xD;
&#xD;
          -  Allergy to copper&#xD;
&#xD;
          -  Arterial insufficiency of the lower extremities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdul H Sultan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Croydon Health Services NHS Trust</affiliation>
  </overall_official>
  <reference>
    <citation>Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15.</citation>
    <PMID>22466974</PMID>
  </reference>
  <reference>
    <citation>Van den Oever R, Hepp B, Debbaut B, Simon I. Socio-economic impact of chronic venous insufficiency. An underestimated public health problem. Int Angiol. 1998 Sep;17(3):161-7.</citation>
    <PMID>9821029</PMID>
  </reference>
  <reference>
    <citation>Motykie GD, Caprini JA, Arcelus JI, Reyna JJ, Overom E, Mokhtee D. Evaluation of therapeutic compression stockings in the treatment of chronic venous insufficiency. Dermatol Surg. 1999 Feb;25(2):116-20. doi: 10.1046/j.1524-4725.1999.08095.x.</citation>
    <PMID>10037516</PMID>
  </reference>
  <reference>
    <citation>Eklof B, Perrin M, Delis KT, Rutherford RB, Gloviczki P; American Venous Forum; European Venous Forum; International Union of Phlebology; American College of Phlebology; International Union of Angiology. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009 Feb;49(2):498-501. doi: 10.1016/j.jvs.2008.09.014.</citation>
    <PMID>19216970</PMID>
  </reference>
  <reference>
    <citation>Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007 Nov;21(6):790-5. doi: 10.1016/j.avsg.2007.07.014.</citation>
    <PMID>17980798</PMID>
  </reference>
  <reference>
    <citation>Borkow G, Gabbay J. Copper as a biocidal tool. Curr Med Chem. 2005;12(18):2163-75. doi: 10.2174/0929867054637617.</citation>
    <PMID>16101497</PMID>
  </reference>
  <reference>
    <citation>O'Gorman J, Humphreys H. Application of copper to prevent and control infection. Where are we now? J Hosp Infect. 2012 Aug;81(4):217-23. doi: 10.1016/j.jhin.2012.05.009. Epub 2012 Jun 26.</citation>
    <PMID>22738611</PMID>
  </reference>
  <reference>
    <citation>Borkow G, Gabbay J, Zatcoff RC. Could chronic wounds not heal due to too low local copper levels? Med Hypotheses. 2008;70(3):610-3. doi: 10.1016/j.mehy.2007.06.006. Epub 2007 Aug 6.</citation>
    <PMID>17689198</PMID>
  </reference>
  <reference>
    <citation>Sen CK, Khanna S, Venojarvi M, Trikha P, Ellison EC, Hunt TK, Roy S. Copper-induced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1821-7. doi: 10.1152/ajpheart.01015.2001.</citation>
    <PMID>11959648</PMID>
  </reference>
  <reference>
    <citation>Tenaud I, Sainte-Marie I, Jumbou O, Litoux P, Dreno B. In vitro modulation of keratinocyte wound healing integrins by zinc, copper and manganese. Br J Dermatol. 1999 Jan;140(1):26-34. doi: 10.1046/j.1365-2133.1999.02603.x.</citation>
    <PMID>10215764</PMID>
  </reference>
  <reference>
    <citation>Ahmed Z, Briden A, Hall S, Brown RA. Stabilisation of cables of fibronectin with micromolar concentrations of copper: in vitro cell substrate properties. Biomaterials. 2004 Feb;25(5):803-12. doi: 10.1016/s0142-9612(03)00596-9.</citation>
    <PMID>14609669</PMID>
  </reference>
  <reference>
    <citation>Uauy R, Olivares M, Gonzalez M. Essentiality of copper in humans. Am J Clin Nutr. 1998 May;67(5 Suppl):952S-959S. doi: 10.1093/ajcn/67.5.952S.</citation>
    <PMID>9587135</PMID>
  </reference>
  <reference>
    <citation>Hostynek JJ, Dreher F, Maibach HI. Human skin penetration of a copper tripeptide in vitro as a function of skin layer. Inflamm Res. 2011 Jan;60(1):79-86. doi: 10.1007/s00011-010-0238-9. Epub 2010 Aug 20. Erratum In: Inflamm Res. 2011 Jun;60(6):611.</citation>
    <PMID>20721598</PMID>
  </reference>
  <reference>
    <citation>Weinberg, I., Lazary, A., Jefidoff, A., Vatine, J.J., Borkow, G., Ohana, N. Safety of using diapers containing copper oxide in chronic care elderly patients. Open Biol J. 2013;6:54-59.</citation>
  </reference>
  <reference>
    <citation>Borkow G, Okon-Levy N, Gabbay J. Copper oxide impregnated wound dressing: biocidal and safety studies. Wounds. 2010 Dec;22(12):301-10.</citation>
    <PMID>25901580</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Croydon Health Services NHS Trust</investigator_affiliation>
    <investigator_full_name>Mr Abdul H Sultan</investigator_full_name>
    <investigator_title>Consultant Obstetrician and Gynaecologist</investigator_title>
  </responsible_party>
  <keyword>Copper Oxide</keyword>
  <keyword>Compression Therapy</keyword>
  <keyword>Chronic Venous Disease</keyword>
  <keyword>Randomised Controlled Trial</keyword>
  <keyword>Lipodermatosclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</mesh_term>
    <mesh_term>Varicose Veins</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Scleroderma, Localized</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 25, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03283800/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03283800/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03283800
org study id: 15/04
nct id: NCT03283800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venous disease has an adverse impact on the quality of life of patients and the NHS spends
      considerable resources on this chronic condition. Copper has been shown to promote new blood
      vessel formation and therefore improve blood supply to the affected area and possibly skin
      conditions. Copper has also been shown to have strong antimicrobial properties. We plan to
      perform a study whereby patients who would normally be given leg stockings will be asked to
      wear similar stockings except that one of the stockings will contain copper fibers. Neither
      the patient nor the clinician will know which is which. Photographs of the leg conditions
      will be taken at baseline, 2, 4 and 8 weeks to evaluate healing. Benefit will be evaluated by
      a symptom questionnaire, severity scoring tools and healing scores taken from the serial
      photographs.
This is a randomised controlled pilot study to assess the feasibility of copper impregnated
      stockings. All patients with CEAP classification 4 in both legs and venous disease identified
      by venous duplex will be recruited from the vascular clinics within Croydon Health Services
      over a period of three months. All patients will be given a patient information sheet
      describing the study prior to consent. Patients will be giving adequate time to read the
      information. Informed consent and the agreement for photography of their legs will be
      obtained. Patients will be assessed at baseline and at 2, 4 and 8 weeks follow-up.

      Copper impregnated stockings:

      All patients will be asked to wear compression stockings (14-18mmHg). These closed-toe and
      below-the-knee stockings are made of 88% nylon, 5% elastin, and 7% spandex and come in
      various sizes. One of the pair will have copper oxide ions permanently attached to the nylon
      fibres and these stockings will contain 2-3% copper ions. The patients will wear a copper
      stocking on one leg (study leg) and a non-copper stocking on the other (control leg). Both
      the patients and the clinicians will be blinded to the copper impregnated stocking.

      Randomisation:

      All stockings are marked with an 'L' for the left or 'R' for the right foot. The manufacturer
      has randomly marked the copper stockings with an 'L' or 'R' and paired these with a
      non-copper stocking. A closed envelope will contain the unique numbers of all the pairs of
      stockings and the information on which sock contains the copper. This envelope will remain
      closed for the whole recruitment period.

      Patient data, history and physical examination:

      Demographic data such as age, ethnicity, height and weight will be collected. Past medical
      history such as concomitant (chronic) diseases and the use of medications will be obtained.
      At each visit, subjective symptoms will be obtained using the Aberdeen Varicose Veins
      Questionnaire (AVVQ). For obtaining objective signs, the CEAP classification and the Venous
      Clinical Severity Scoring (VCSS) will be performed for grading the severity of the venous
      insufficiency per leg individually, and photographs with the Eykona® 3D camera will be taken.
      All data sets will be coded and anonymised. The data will be stored in a secure room within
      the Trust. All electronic data will be stored within password protected IT system within the
      Trust, which is only accessible by the clinical and research team.

      Eykona® Wound Measurement System:

      Skin changes associated with lipodermatosclerosis such as erythema, induration,
      hyperpigmentation and white atrophy, will be measured using the Eykona® Wound Measuring
      System (Type EYK10001). This system contains a 3D portable camera with software that enables
      precise measurements of wound size and tissue condition. Photographs will be taken at each
      visit. The surface area of the skin changes will be calculated.

      Statistical analysis:

      Statistical analysis will be performed using SPSS version 20.0 or higher. The CEAP
      classification, the Venous Clinical Severity Score and the AVVQ score at the 2, 4, and 8
      weeks assessment will be compared with the baseline scores. The length, width and surface
      area of the skin condition from the leg with the copper will be compared with the control leg
      and the measurements at the 2, 4, and 8 weeks assessment will be compared with the baseline
      measurements. Paired t-test will be used for continuous data at baseline and a multilevel
      (mixed) regression model will be used to analyse the change over time.

      Sample size calculation:

      The sample size for this study will be 15. This number is based on the prevalence of the
      disease in this hospital over three months' time. There is no existing data available to
      allow a sample size calculation. The data collection of this pilot study will enable power
      calculation for a larger multicentre study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All participants will be asked to wear compression stockings. One of the pair will have copper oxide ions permanently attached to the nylon fibres and these stockings will contain 2-3% copper ions. The participants will wear a copper stocking on one leg (study leg) and a non-copper stocking on the other (control leg).
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: All stockings are marked with an 'L' for the left or 'R' for the right foot. The manufacturer has randomly marked the copper stockings with an 'L' or 'R' and paired these with a non-copper stocking. A closed envelope will contain the unique numbers of all the pairs of stockings and the information on which stocking contains the copper. This envelope will remain closed for the whole recruitment period and throughout analysis of the results.
measure: Aberdeen Varicose Vein Questionnaire (AVVQ)
time frame: 2 weeks
description: Validated questionnaire consisting of 13 questions on signs and symptoms of chronic venous insufficiency for each leg seperately and questions on compression stocking usage and quality of life. The scoring of the questionnaire is from 0, which indicates no effect on the patient, to 100, which indicates a severe effect.
measure: Venous Clinical Severity Scoring (VCSS)
time frame: 24 hours
description: Assessment tool consisting of 10 items: pain, varicose veins, oedema, skin pigmentation, inflammation, induration, ulceration (number, size and duration) and use of compression therapy, which are scored on a severity scale from 0 to 3.
measure: Lipodermatosclerosis surface area
time frame: 2, 4 and 8 weeks after wearing compression stockings
description: Surface area of the affected skin measured using 3D photographs with the Eykona® Wound Measuring System (Type EYK10001).
arm group label: Copper impregnated compression stocking
arm group type: Experimental
description: Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.
arm group label: Normal compression stocking
arm group type: Placebo Comparator
description: Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks
intervention type: Other
intervention name: Copper impregnated compression stocking
description: Copper impregnated compression stocking
arm group label: Copper impregnated compression stocking
intervention type: Other
intervention name: Normal compression stocking
description: Normal compression stocking without copper
arm group label: Normal compression stocking
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Abdul H Sultan
role: Principal Investigator
affiliation: Croydon Health Services NHS Trust
citation: Rabe E, Guex JJ, Puskas A, Scuderi A, Fernandez Quesada F; VCP Coordinators. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol. 2012 Apr;31(2):105-15.
PMID: 22466974
citation: Van den Oever R, Hepp B, Debbaut B, Simon I. Socio-economic impact of chronic venous insufficiency. An underestimated public health problem. Int Angiol. 1998 Sep;17(3):161-7.
PMID: 9821029
citation: Motykie GD, Caprini JA, Arcelus JI, Reyna JJ, Overom E, Mokhtee D. Evaluation of therapeutic compression stockings in the treatment of chronic venous insufficiency. Dermatol Surg. 1999 Feb;25(2):116-20. doi: 10.1046/j.1524-4725.1999.08095.x.
PMID: 10037516
citation: Eklof B, Perrin M, Delis KT, Rutherford RB, Gloviczki P; American Venous Forum; European Venous Forum; International Union of Phlebology; American College of Phlebology; International Union of Angiology. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009 Feb;49(2):498-501. doi: 10.1016/j.jvs.2008.09.014.
PMID: 19216970
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responsible party type: Principal Investigator
investigator affiliation: Croydon Health Services NHS Trust
investigator full name: Mr Abdul H Sultan
investigator title: Consultant Obstetrician and Gynaecologist
mesh term: Venous Insufficiency
mesh term: Varicose Veins
mesh term: Dermatitis
mesh term: Scleroderma, Localized
mesh term: Copper
sharing ipd: No
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