Improvement of Sensibility in the Sole of the Foot in Diabetic Patients, Induced by EMLA-application to the Lower Leg - a Double Blind Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)
研究概览
简要总结
Sensory input from the foot as well as all other body parts results in activation of sensory cortex.
It is well known that the cortical body map is experienced-dependant and can rapidly change in response to changes in activity and sensory input from the periphery [10-12]. Increased activity and sensory input from the hand results in expansion of the cortical hand representation [13-15], while decreased sensory input, for instance by anaesthesia, amputation or nerve injury, results in shrinkage of the cortical hand representation [16-21]. Due to the constant ongoing "cortical competition" between body parts the adjacent cortical areas expand and take over the silent area, deprived of sensory input.
The investigators have recently described striking examples of such rapid cortical re-organisations induced by selective cutaneous anaesthesia of the forearm: application of EMLA cream to the volar aspect of the forearm results in improved sensory functions of the hand [18] linked to expansion of the hand representational area in sensory cortex . In analogy, EMLA application to the lower leg in healthy controls results in improved sensory functions in the sole of the foot linked to expansion of the foot representational area in sensory cortex.
To test the hypothesis that EMLA application to the lower leg of diabetic patients will result in improved sensory functions in the sole of the foot as well as expansion of the foot representation in sensory cortex. The investigators hypothesize that repeated applications of EMLA will result in a long lasting sensibility improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-75 years) suffering from diabetes with subjective sensory impairment in the sole of the foot.
排除标准
- •Patients with painful neuropathy or established ulcer formation in toes or sole of the foot, known hypersensitivity to local anaesthetics, major vascular reconstructions, communication problems due to severe language problems.
- •Patients with pacemakers or magnetic implants or suffering from claustrophobia will not be subjected to fMRI-investigation.
研究组 & 干预措施
EMLA cream
干预措施: EMLA cream (Drug)
Placebo cream
A placebo cream identical in appearance and consistency to the experimental cream
干预措施: EMLA cream (Drug)
结局指标
主要结局
Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)
时间窗: Screening, before application, 90 min after application, 24 hours after application
次要结局
- fMRI(fMRI-examination, before application, 90 min after application, 24 hours after application)
- MRI(MRI-examination, before application, 90 min after application, 24 hours after application)
研究者
Goran Lundborg
Professor Göran Lundborg
Lund University Hospital
