Prospective Observational Series to Establish the Haemodynamic Efficacy and Tolerability of gekoTM Device in Patients With Lower Limb Vascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Effect of geko™ on blood volume flow through the femoral artery
研究概览
简要总结
A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.
详细描述
The geko™ device, (CE 558928; British Standards Institute notified body 0086),is a wearable, discrete, self-contained stimulation unit that adheres to the skin (see www.gekodevices.com). The, geko™ triggers small electrical impulses that gently activate the common peroneal nerve within the popliteal fossa, behind the knee, in turn activating the venous muscle pumps of the calf and foot. Substantive increases in lower limb blood flow have been demonstrated to improve arterial, venous and microcirculatory blood flow with no reported morbidity.
Environmental Conditions The examinations will be carried out in a designated temperature controlled clinical room in the Vascular Lab at Hull Royal Infirmary. Participants will be required to abstain from vigorous exercise, nicotine, caffeine and fatty foods prior to their examination. They will be required to wear light garments with their legs exposed.
The geko™ device will be applied to outer/ posterior aspect of the knee whilst the subjects are semi-recumbent, with their knees flexed. The participants will be given 30 minutes in the quiet, environmentally controlled room prior to commencement of measurement to enable equilibration.
Assessments Participants will complete the McGill Pain questionnaire prior to device activation Participants will have the geko™ device applied whilst semi-recumbent with their knees flexed. The intensity will be increased until visible muscle stimulation is evident (concentric isotonic contractions) or until patient tolerance is reached
- Laser Doppler imaging will be used to assess microcirculation flow on the dorsum of both feet at:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age >18 years
- •Absence of haematological disorders or DVT (deep vein thrombosis) in the preceding 12 months
- •Intact cutaneous sensations to nocioception in the lower limb, as determined by the investigator
- •Intact healthy skin at site of application
- •On effective contraception if sexually active - oral contraceptive pill (> 3 months use), condoms, intrauterine contraceptive device, depot injection
- •Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements
排除标准
- •History of haematological disorder or DVT in the preceding 12 months
- •Pregnant or planning to become pregnant during study duration
- •Pacemakers or implantable defibrillators
- •Use of any other neuro-modulation device
- •Current use of TENS (transcutaneous electrical nerve stimulation) in pelvic region, back or legs
- •Use of investigational drug/device therapy within past 4 weeks that may interfere with this study.
- •Significant varicose veins or lower limb ulceration.
- •Recent surgery (such as abdominal, gynaecological, hip knee replacement).
- •Recent trauma to lower limbs.
- •Chronic Obesity (BMI Index >34).
- •Any medication judged to be significant by the Principal Investigator.
- •Any significant illness during the four (4) weeks preceding the screening period of the study.
研究组 & 干预措施
geko™ electrical stimulation
Applied to stimulate peroneal nerve unilaterally
干预措施: geko™ electrical stimulation (Device)
结局指标
主要结局
Effect of geko™ on blood volume flow through the femoral artery
时间窗: Study day i.e. 1 day
Measured with ultrasound doppler
次要结局
- Effect of geko™ on venous blow flow(Study day i.e. 1 day)
- Effect of geko™ on microcirculatory flow(Study day i.e. 1 day)
- Effect of geko™ on patients symptoms(study day i.e. 1 day)
- Acceptability and tolerability of geko™ device(study day i.e. 1 day)
- Effect of gekoTM on calf circumference(Study day i.e. 1 day)
- Establish whether effects of geko™ are local or systemic(Study day i.e. 1 day)