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Clinical Trials/NCT00959595
NCT00959595
Completed
Phase 3

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 site in 1 country32 target enrollmentNovember 2008
InterventionsEMLA cream

Overview

Phase
Phase 3
Intervention
EMLA cream
Conditions
Diabetes Mellitus
Sponsor
Lund University Hospital
Enrollment
32
Locations
1
Primary Endpoint
Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
January 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Goran Lundborg

Professor Göran Lundborg

Lund University Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients (18-75 years) suffering from diabetes with subjective sensory impairment in the sole of the foot.

Exclusion Criteria

  • 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.

Arms & Interventions

EMLA cream

Intervention: EMLA cream

Placebo cream

A placebo cream identical in appearance and consistency to the experimental cream

Intervention: EMLA cream

Outcomes

Primary Outcomes

Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)

Time Frame: Screening, before application, 90 min after application, 24 hours after application

Secondary Outcomes

  • 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)

Study Sites (1)

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