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
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|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|
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
- 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.
- 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.
- 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).
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
|Principal Investigator:||Abdul H Sultan||Croydon Health Services NHS Trust|