A Clinical Investigation Evaluating the Efficacy of Gradusox™ Compression Hosiery at Enhancing Dermal Oxygen Levels in Healthy Participants Post-varicose Vein Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- OxyHb
研究概览
简要总结
The primary objective is to evaluate the effect of Gradusox™ compression hosiery on the local tissue oxygenation and compare this effect against that achieved by standard compression hosiery.
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) first, GraduSOX on their right leg and Sigvaris on their left leg, then GraduSOX on their left leg and Sigvaris on their right leg, or b) first, GraduSOX on their left leg and Sigvaris on their right leg, then GraduSOX on their right leg and Sigvaris on their left leg.
Participants will attend the clinic and be fitted with their stockings. Non-invasive probes will be taped to the skin above the inner ankle on both legs - these take measurements for SO2, oxyHb and deoxyHb every second. Measurements for these variables will be taken for 15 minutes whilst participants are not wearing stockings, as well as with stockings (worn in the order assigned to them). During these 15 minutes, participants will lie in supine for 5 minutes, then in sitting position for 5 minutes, then will return to supine for the last 5 minutes.
Between each stocking, participants will be asked to take a 10 minute walk and return to the recliner in supine to re-equilibrate for a further 15 minutes.
The total time that measurements are taken for per participant is 50 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
OxyHb
时间窗: 50 minutes
Oxyhaemoglobin
SO2
时间窗: 50 minutes
Transcutaneous oxygen saturation
DeoxyHb
时间窗: 50 minutes
Deoxyhaemoglobin
次要结局
未报告次要终点