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

NCT ID: NCT00959595

Last Updated: 2013-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-01-31

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; neuropathy; foot; sensibility; brain plasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EMLA cream

Group Type: EXPERIMENTAL

EMLA cream

Intervention Type: DRUG

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.

EMLA cream

Intervention Type: DRUG

50g applied according to description of intervention

Placebo cream

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

Group Type: PLACEBO_COMPARATOR

EMLA cream

Intervention Type: DRUG

50g applied according to description of intervention

Interventions

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.

Intervention Type: DRUG

EMLA cream

50g applied according to description of intervention

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Goran Lundborg

Professor Göran Lundborg

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Göran Lundborg, Professor

Role: PRINCIPAL_INVESTIGATOR

Dpt of Hand Surgery, Malmö University Hospital, Lund University, Sweden

Locations

Department of Hand Surgery, Malmö University Hospital

Malmo, , Sweden

Countries

Sweden

References

Lundborg GN, Bjorkman AC, Rosen BN, Nilsson JA, Dahlin LB. Cutaneous anaesthesia of the lower leg can improve sensibility in the diabetic foot. A double-blind, randomized clinical trial. Diabet Med. 2010 Jul;27(7):823-9. doi: 10.1111/j.1464-5491.2010.03014.x.

Reference Type: RESULT

PMID: 20636964 (View on PubMed)

Other Identifiers

2008-001834-29

Identifier Type: -

Identifier Source: org_study_id