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Copper Impact on Venous Insufficiency and Lipodermatosclerosis (CIVIL)

Primary Purpose

Lipodermatosclerosis, Chronic Venous Insufficiency, Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Copper impregnated compression stocking
Normal compression stocking
Sponsored by
Croydon Health Services NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lipodermatosclerosis focused on measuring Copper Oxide, Compression Therapy, Chronic Venous Disease, Randomised Controlled Trial, Lipodermatosclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients
  • CEAP classification 4 in both legs
  • Venous disease confirmed by venous duplex
  • Ability to understand and read the patient information sheet (in English)
  • Ability to give informed consent

Exclusion Criteria:

  • Inability to give consent
  • Pregnancy
  • Current ulceration
  • Wilson's disease
  • Allergy to copper
  • Arterial insufficiency of the lower extremities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Copper impregnated compression stocking

    Normal compression stocking

    Arm Description

    Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.

    Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks

    Outcomes

    Primary Outcome Measures

    Aberdeen Varicose Vein Questionnaire (AVVQ)
    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.
    Venous Clinical Severity Scoring (VCSS)
    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.

    Secondary Outcome Measures

    Lipodermatosclerosis surface area
    Surface area of the affected skin measured using 3D photographs with the Eykona® Wound Measuring System (Type EYK10001).

    Full Information

    First Posted
    September 13, 2017
    Last Updated
    September 14, 2017
    Sponsor
    Croydon Health Services NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03283800
    Brief Title
    Copper Impact on Venous Insufficiency and Lipodermatosclerosis
    Acronym
    CIVIL
    Official Title
    Impact of Copper Compression Stockings on Venous Insufficiency and Lipodermatosclerosis: a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 23, 2015 (Actual)
    Primary Completion Date
    January 9, 2017 (Actual)
    Study Completion Date
    January 9, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Croydon Health Services NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipodermatosclerosis, Chronic Venous Insufficiency, Venous Insufficiency, Varicose Veins
    Keywords
    Copper Oxide, Compression Therapy, Chronic Venous Disease, Randomised Controlled Trial, Lipodermatosclerosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Copper impregnated compression stocking
    Arm Type
    Experimental
    Arm Description
    Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.
    Arm Title
    Normal compression stocking
    Arm Type
    Placebo Comparator
    Arm Description
    Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Copper impregnated compression stocking
    Intervention Description
    Copper impregnated compression stocking
    Intervention Type
    Other
    Intervention Name(s)
    Normal compression stocking
    Intervention Description
    Normal compression stocking without copper
    Primary Outcome Measure Information:
    Title
    Aberdeen Varicose Vein Questionnaire (AVVQ)
    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.
    Time Frame
    2 weeks
    Title
    Venous Clinical Severity Scoring (VCSS)
    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.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Lipodermatosclerosis surface area
    Description
    Surface area of the affected skin measured using 3D photographs with the Eykona® Wound Measuring System (Type EYK10001).
    Time Frame
    2, 4 and 8 weeks after wearing compression stockings

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients CEAP classification 4 in both legs Venous disease confirmed by venous duplex Ability to understand and read the patient information sheet (in English) Ability to give informed consent Exclusion Criteria: Inability to give consent Pregnancy Current ulceration Wilson's disease Allergy to copper Arterial insufficiency of the lower extremities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdul H Sultan
    Organizational Affiliation
    Croydon Health Services NHS Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    Citation
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    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.
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    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.
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    Copper Impact on Venous Insufficiency and Lipodermatosclerosis

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