Copper Impact on Venous Insufficiency and Lipodermatosclerosis
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2017 |
| First Submitted: | 09/12/2017 |
| Estimated Enrollment Submitted: | 09/12/2017 |
| First Posted: | 09/13/2017 |
| Last Update Submitted: | 09/13/2017 |
| Last Update Posted: | 09/14/2017 |
| Actual Study Start Date: | 09/22/2015 |
| Estimated Primary Completion Date: | 01/08/2017 |
| Estimated Study Completion Date: | 01/08/2017 |
Condition or disease
Intervention/treatment
Other: Copper impregnated compression stocking
Other: Normal compression stocking
Phase
Arm Groups
| 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 |
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Aberdeen Varicose Vein Questionnaire (AVVQ) [2 weeks]
2. Venous Clinical Severity Scoring (VCSS) [24 hours]
Secondary Outcome Measures
1. Lipodermatosclerosis surface area [2, 4 and 8 weeks after wearing compression stockings]
