Prospective Assessment to Evaluate the Ease of Application and Removal of GraduSOX™ VLU Kit Compared to Sigvaris™ Ulcer X VLU Kit, and Comfort in Use by Healthy Patients Who Have Completed Venous Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
研究概览
简要总结
The aims of this study are to evaluate the comfort, and ease of application and removal, of GraduSOX™ compression stockings compared to standard compression stockings of the same compression class.
详细描述
After being informed about the study, all participants giving written informed consent will be randomised by closed envelope randomisation to either a) GraduSOX on their right leg and Sigvaris on their left leg, or b) Sigvaris on their right leg and GraduSOX on their left leg. At Day 1, participants will attend the clinic and be fitted with their stockings and given an Evaluation Form. The Evaluation Form has four sections to be completed on Day 1, Day 2, Day 4 and Day 8 of the study. Each section asks multiple choice questions related to the comfort and ease of applying and removing each stocking.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 and over.
- •Have known previous venous insufficiency that has been treated.
- •Have no known current contraindication to the wearing of graduated compression hosiery.
- •Have an ankle brachial pressure index (ABPI) between 0.8-1.
- •Have no active ulceration.
- •Are physically able to apply and remove hosiery kits safely.
- •Have had successful surgery at The Whiteley Clinic and have had at least one follow-up to show no residual venous disease.
排除标准
- •Under the age of
- •Have known arterial insufficiency (an ABPI of below 0.8).
- •Have active ulceration.
- •Be physically unable to put stocking on their own legs.
- •Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, significant ankle oedema.
- •Unable to give informed consent.
- •Pregnant.
- •Fragile skin that may be damaged whilst trying to apply or remove compression stockings.
- •Previous DVT or complicated varicose veins that were not able to be completely treated and left residual venous reflux disease.
结局指标
主要结局
Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
时间窗: Day 8 of 8
Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'.
Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
时间窗: Day 8 of 8
Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'.
Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
时间窗: Day 8 of 8
Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'.
Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
时间窗: Day 8 of 8
Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'.
Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
时间窗: Day 8 of 8
Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'.
Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
时间窗: Day 8 of 8
Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'.
次要结局
未报告次要终点