Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-02 @ 5:48 AM
Study NCT ID:
NCT00959595
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2009-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Sensibility in the Foot in Diabetic Patients Induced by EMLA-application to the Lower Leg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}], 'ancestors': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Touch thresholds in the sole of the foot (Semmes-Weinstein monofilaments)', 'timeFrame': 'Screening, before application, 90 min after application, 24 hours after application'}], 'secondaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'MRI-examination, before application, 90 min after application, 24 hours after application'}, {'measure': 'fMRI', 'timeFrame': 'fMRI-examination, before application, 90 min after application, 24 hours after application'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'neuropathy', 'foot', 'sensibility', 'brain plasticity'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '20636964', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Sensory input from the foot as well as all other body parts results in activation of sensory cortex.\n\nIt 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.\n\nThe 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18-75 years) suffering from diabetes with subjective sensory impairment in the sole of the foot.\n\nExclusion Criteria:\n\n* 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.\n* Patients with pacemakers or magnetic implants or suffering from claustrophobia will not be subjected to fMRI-investigation.'}, 'identificationModule': {'nctId': 'NCT00959595', 'briefTitle': 'Improvement of Sensibility in the Foot in Diabetic Patients Induced by EMLA-application to the Lower Leg', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': 'Improvement of Sensibility in the Sole of the Foot in Diabetic Patients, Induced by EMLA-application to the Lower Leg - a Double Blind Study', 'orgStudyIdInfo': {'id': '2008-001834-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMLA cream', 'interventionNames': ['Drug: EMLA cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cream', 'description': 'A placebo cream identical in appearance and consistency to the experimental cream', 'interventionNames': ['Drug: EMLA cream']}], 'interventions': [{'name': 'EMLA cream', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['EMLA cream']}, {'name': 'EMLA cream', 'type': 'DRUG', 'description': '50g applied according to description of intervention', 'armGroupLabels': ['EMLA cream', 'Placebo cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Department of Hand Surgery, Malmö University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Göran Lundborg, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dpt of Hand Surgery, Malmö University Hospital, Lund University, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Göran Lundborg', 'investigatorFullName': 'Goran Lundborg', 'investigatorAffiliation': 'Lund University Hospital'}}}}