Varicose Veins Clinical Trial
Official title:
Impact of Copper Compression Stockings on Venous Insufficiency and Lipodermatosclerosis: a Randomised Controlled Trial
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.
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