Prospective Assessment to Evaluate the Comfort of GraduCheck® in Use by Healthy Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 主要终点
- Comfort
研究概览
简要总结
The purpose of this service evaluation is to evaluate the comfort in use of GraduCheck® by volunteers, under standard compression bandages.
详细描述
Study Description
This is a prospective evaluation study comparing GraduCheck® under the Urgo K2 compression bandage system.
For each volunteer, the study is to be carried out over 7 days. This includes one initial visit to the clinic (The Woundcare Consultants Clinic - with a Covid-secure protocol), and the completion of an Evaluation Form at home at 24 hours, 3 days, and 7 days after the initial visit.
Those volunteers who are already on the GraduCheck® evaluation study (Prospective Assessment to Evaluate the Use of GraduCheck® in Enabling Experienced Tissue Viability Nurses to Achieve Ideal Sub-Bandage Pressures in Healthy Volunteers. IRAS: 309519) who wish to continue onto this linked study will already be in the clinic having undergone six compression system changes already, with the final compression system being one of the two involved in this study.
Volunteers should be able to remove the compression themselves at the end of the study but are welcome to return for a nurse to remove it, if preferred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 an ankle brachial pressure index (ABPI) between 0.8-1.2 (at assessment)
- •Have no active ulceration
排除标准
- •Under the age of 18
- •Unable to wear compression bandages of hosiery for any reason
- •Unable to walk unaided and at normal speed for at least one mile
- •Previous history of deep vein thrombosis
- •Have known arterial insufficiency (an ABPI of below 0.8) (at assessment)
- •Unable to tolerate a cuff at 40 mmHg around ankle (at assessment)
- •Have active ulceration
- •Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, or significant ankle oedema
- •Unable to give informed consent
- •Fragile skin that may be damaged whilst trying to apply compression bandaging
结局指标
主要结局
Comfort
时间窗: 7 days
Comfort of leg with compression and GraduCheck device compared with comfort of compression alone
次要结局
未报告次要终点
研究者
Mark Whiteley
Consultant Venous Surgeon
The Whiteley Clinic