Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-04-18 @ 4:02 AM
Study NCT ID:
NCT01963559
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cutaneous Microcirculation and Diabetic Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000287', 'term': 'Administration, Topical'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutaneous blood flow', 'timeFrame': 'Within 3 months after inclusion'}], 'secondaryOutcomes': [{'measure': 'Effect of neuropathy on PIV impairment', 'timeFrame': 'Within 3 months after inclusion', 'description': 'Difference in skin vascular response to local application of pressure (PIV) with and without topical application of a local anesthetic cream Lidocaine / prilocaine in all diabetic patients (with and without MPP).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Foot Proned Patients']}, 'descriptionModule': {'briefSummary': '15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Men and Women\n* Presence of diabetes\n* Signed acknowledgement form\n\nExclusion Criteria:\n\n* No signed acknowledgement form\n* patients under 18 year-old'}, 'identificationModule': {'nctId': 'NCT01963559', 'acronym': 'M2P2', 'briefTitle': 'Cutaneous Microcirculation and Diabetic Foot', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Cutaneous Microcirculation and Diabetic Foot', 'orgStudyIdInfo': {'id': '2011.661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Diabetic patients with MPP', 'interventionNames': ['Drug: Lidocaine/prilocaine 1g (topical administration)']}, {'type': 'OTHER', 'label': 'Diabetic patients without MPP', 'interventionNames': ['Drug: Lidocaine/prilocaine 1g (topical administration)']}], 'interventions': [{'name': 'Lidocaine/prilocaine 1g (topical administration)', 'type': 'DRUG', 'description': 'Cutaneous blood flow measurement using laser Doppler', 'armGroupLabels': ['Diabetic patients with MPP', 'Diabetic patients without MPP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}