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Copper Impact on Venous Insufficiency and Lipodermatosclerosis (CIVIL)

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ClinicalTrials.gov Identifier: NCT03283800
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Mr Abdul H Sultan, Croydon Health Services NHS Trust

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.

Condition or disease Intervention/treatment Phase
Lipodermatosclerosis Chronic Venous Insufficiency Venous Insufficiency Varicose Veins Other: Copper impregnated compression stocking Other: Normal compression stocking Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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).
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.
Primary Purpose: Supportive Care
Official Title: Impact of Copper Compression Stockings on Venous Insufficiency and Lipodermatosclerosis: a Randomised Controlled Trial
Actual Study Start Date : September 23, 2015
Actual Primary Completion Date : January 9, 2017
Actual Study Completion Date : January 9, 2017


Arm Intervention/treatment
Experimental: Copper impregnated compression stocking
Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.
Other: Copper impregnated compression stocking
Copper impregnated compression stocking

Placebo Comparator: Normal compression stocking
Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks
Other: Normal compression stocking
Normal compression stocking without copper




Primary Outcome Measures :
  1. Aberdeen Varicose Vein Questionnaire (AVVQ) [ Time Frame: 2 weeks ]
    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.

  2. Venous Clinical Severity Scoring (VCSS) [ Time Frame: 24 hours ]
    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 :
  1. Lipodermatosclerosis surface area [ Time Frame: 2, 4 and 8 weeks after wearing compression stockings ]
    Surface area of the affected skin measured using 3D photographs with the Eykona® Wound Measuring System (Type EYK10001).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283800


Sponsors and Collaborators
Croydon Health Services NHS Trust
Investigators
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Principal Investigator: Abdul H Sultan Croydon Health Services NHS Trust
  Study Documents (Full-Text)

Documents provided by Mr Abdul H Sultan, Croydon Health Services NHS Trust:
Informed Consent Form  [PDF] March 17, 2015


Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mr Abdul H Sultan, Consultant Obstetrician and Gynaecologist, Croydon Health Services NHS Trust
ClinicalTrials.gov Identifier: NCT03283800     History of Changes
Other Study ID Numbers: 15/04
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mr Abdul H Sultan, Croydon Health Services NHS Trust:
Copper Oxide
Compression Therapy
Chronic Venous Disease
Randomised Controlled Trial
Lipodermatosclerosis
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Dermatitis
Scleroderma, Localized
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Connective Tissue Diseases
Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs