A Single Centre Open Label Pilot Study Measuring Lower Limb Physiology in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The acute effect of the geko™ device on ambulatory venous pressure in patients with venous leg ulcers will be evaluated when sitting, standing or supine
研究概览
简要总结
This is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester.
Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine
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 99 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 and able to give informed consent
- •Willing and able to follow the requirements of the protocol
- •Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 1 cm2 and less than 10 cm in maximum diameter,
- •ABPI of ≥0.8
- •Patient treated with 4 layer compression bandaging
排除标准
- •Wound infection either acute or chronic
- •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 that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
- •Recent trauma to the lower limbs
- •Size of leg incompatible with the geko™ device.
- •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, or less than 2cm.
- •Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)
结局指标
主要结局
The acute effect of the geko™ device on ambulatory venous pressure in patients with venous leg ulcers will be evaluated when sitting, standing or supine
时间窗: 2 hours
using Lectromed Multitrace II venous pressure recording system, this will measure Ambulatory venous pressure which will show any influence, if any, gekoTM has on AVP.
次要结局
- The acute effect of the geko™ device on lower leg venous transit times(2 hours)
- Adverse events assessments(2 hours)
- The acute effect of the geko™ device on wound tissue oxygen levels(2 hours)
- The effect of the geko™ device on lower leg microcirculation(2 hours)