NCT02482038已完成不适用
A Single Centre Open Label Pilot Study Measuring Lower Limb Blood Flow in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ultra sound measurements of haemodynamics
研究概览
简要总结
This study is designed to look at the effect of the geko device on the circulation in lower limbs of participants with venous leg ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Intact healthy skin at the site of device application
- •Able to understand the Patient Information Sheet
- •Willing to give informed consent
- •Willing to follow the requirements of the protocol
- •Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
- •ABPI of 0.8 or greater
排除标准
- •History of significant haematological disorders or DVT with the preceding six months
- •Pacemakers or implantable defibrillators
- •Use of any other neuro-modulation device
- •Current use of TENS in pelvic region, back or legs
- •Use of investigational drug or device within the past 4 weeks that may interfere with this study
- •Recent surgery (such as abdominal, gynaecological, hip or knee replacement)
- •Recent trauma to the lower limbs
- •Size of leg incompatible with the geko™ device.
- •Chronic obesity (BMI > 34)
- •Any medication deemed to be significant by the Investigator
- •Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension
- •Diabetic subjects with advanced small vessel disease
结局指标
主要结局
Ultra sound measurements of haemodynamics
时间窗: 10mins
次要结局
- Adverse event rate(2 hrs)
- patient rated tolerability(2 hrs)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Peripheral Vascular Disease and Nerve StimulationCritical Limb IschaemiaClaudicationUlcersVaricose VeinsPost AngioplastyNCT01942941Hull University Teaching Hospitals NHS Trust80
已完成
不适用
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ DeviceVenous Leg UlcerNCT02884323Firstkind Ltd7
已完成
1 期
Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the LegPeripheral Vascular DiseaseNCT00538226Rosenblum, Jonathan I., DPM
撤回
不适用
Surgical Revascularisation and Nerve Stimulation TrialPeripheral Arterial Occlusive DiseaseNCT01938924Hull University Teaching Hospitals NHS Trust
终止
不适用
Speckle Study: In Arterial, Mixed and Diabetic Foot UlcersLeg UlcerNCT03186560Firstkind Ltd34