Improvement of Sensibility in the Foot in Diabetic Patients Induced by EMLA-application to the Lower Leg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Goran Lundborg, Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00959595
First received: August 12, 2009
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: EMLA cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Sensibility in the Sole of the Foot in Diabetic Patients, Induced by EMLA-application to the Lower Leg - a Double Blind Study

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments) [ Time Frame: Screening, before application, 90 min after application, 24 hours after application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI [ Time Frame: MRI-examination, before application, 90 min after application, 24 hours after application ] [ Designated as safety issue: No ]
  • fMRI [ Time Frame: fMRI-examination, before application, 90 min after application, 24 hours after application ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMLA cream Drug: EMLA cream
The study subjects are treated either by 50 g of a local anesthetic agent containing 2.5% Lidocaine and 2.5% Prilocaine (EMLA®, AstraZeneca - Södertälje, Sweden) or a placebo cream, applied to the lower leg. The cream is applied under occlusive bandage (plastic foam and a tube) for 1.5 hours circumferential to the lower leg 10-12 cm distally of the tibial tuberosity and the malleolus at ankle level. Administration of the treatment cream as well as removal after 1,5 hour and at sensory assessment after 1.5 hour and 24 hours, and interviewing the patient about subjective experience from the treatment are performed by an independent research nurse, not involved in the sensory assessment.
Drug: EMLA cream
50g applied according to description of intervention
Placebo Comparator: Placebo cream
A placebo cream identical in appearance and consistency to the experimental cream
Drug: EMLA cream
50g applied according to description of intervention

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959595

Locations
Sweden
Department of Hand Surgery, Malmö University Hospital
Malmö, Sweden, SE-205 02
Sponsors and Collaborators
Lund University Hospital
Investigators
Principal Investigator: Göran Lundborg, Professor Dpt of Hand Surgery, Malmö University Hospital, Lund University, Sweden
  More Information

Publications:
Responsible Party: Goran Lundborg, Professor Göran Lundborg, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00959595     History of Changes
Other Study ID Numbers: 2008-001834-29
Study First Received: August 12, 2009
Last Updated: December 13, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University Hospital:
Diabetes mellitus
neuropathy
foot
sensibility
brain plasticity

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
EMLA
Anesthetics, Combined
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014