Impact of Copper Compression Stockings on Venous Insufficiency and Lipodermatosclerosis: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Aberdeen Varicose Vein Questionnaire (AVVQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to give consent
- •Pregnancy
- •Current ulceration
- •Wilson's disease
- •Allergy to copper
- •Arterial insufficiency of the lower extremities
研究组 & 干预措施
Copper impregnated compression stocking
Copper compression stocking containing 2-3% copper ions to be worn on one leg, daily for 8 weeks.
干预措施: Copper impregnated compression stocking (Other)
Normal compression stocking
Similar compression stocking without copper to be worn on the other leg, daily for 8 weeks
干预措施: Normal compression stocking (Other)
结局指标
主要结局
Aberdeen Varicose Vein Questionnaire (AVVQ)
时间窗: 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)
时间窗: 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.
次要结局
- Lipodermatosclerosis surface area(2, 4 and 8 weeks after wearing compression stockings)
研究者
Mr Abdul H Sultan
Consultant Obstetrician and Gynaecologist
Croydon Health Services NHS Trust