Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-06 @ 5:01 AM
Study NCT ID:
NCT03213093
Status:
RECRUITING
Last Update Posted:
2021-07-26
First Post:
2017-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pressure and Diabetic Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], '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'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-23', 'studyFirstSubmitDate': '2017-07-06', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of incidence of diabetic foot ulcer', 'timeFrame': 'At any time during a 3 years follow-up', 'description': 'A diabetic foot ulcer is defined as a breakdown in the skin under malleolus'}], 'secondaryOutcomes': [{'measure': 'Neurovascular response to pressure', 'timeFrame': 'At the end of the 3-year follow-up', 'description': 'Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Diabetic Foot Ulcer', 'Plantar pressure'], 'conditions': ['Diabetes and Risk of Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Type 2 diabetic subject\n* Absence of active diabetic foot ulcer\n* Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:\n* absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"\n* alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1"\n* alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2"\n* History of diabetic foot ulcer for the "grade 3"\n* Signature of consent to participate in the study\n\nExclusion Criteria:\n\n* Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day\n* Pregnancy\n* Congenital methemoglobinemia.\n* Porphyria\n* Skin injured on the tibia, whatever the lesion\n* Recent major cardiovascular history (less than 3 months)\n* Severe renal disease (serum creatinine\\> 300 μmol.l-1)'}, 'identificationModule': {'nctId': 'NCT03213093', 'acronym': 'PIV & MPP', 'briefTitle': 'Pressure and Diabetic Foot', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '69HCL16_0168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Diabetic patients with a risk of diabetic foot ulcer', 'interventionNames': ['Other: Measure of cutaneous microcirculation']}], 'interventions': [{'name': 'Measure of cutaneous microcirculation', 'type': 'OTHER', 'description': 'Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine', 'armGroupLabels': ['Diabetic patients with a risk of diabetic foot ulcer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien VOUILLARMET, MD', 'role': 'CONTACT', 'email': 'julien.vouillarmet@chu-lyon.fr'}], 'facility': "service d'endocrinologie, Centre Hospitalier Lyon Sud", 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Julien Vouillarmet', 'role': 'CONTACT', 'email': 'julien.vouillarmet@chu-lyon.fr', 'phone': '4-78-86-14-89', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}