跳至主要内容
临床试验/NCT00959595
NCT00959595已完成3 期

Improvement of Sensibility in the Sole of the Foot in Diabetic Patients, Induced by EMLA-application to the Lower Leg - a Double Blind Study

Lund University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: EMLA cream (Drug)

Placebo cream

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Goran Lundborg

Professor Göran Lundborg

Lund University Hospital

研究点 (1)

Loading locations...

相似试验

Improvement of Sensibility in the Foot in Diabetic... | 临床试验