Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02405767
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioimPEDance of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in impedance', 'timeFrame': '3 months', 'description': 'Correlation between electrical impedance of the wound measured with ECG electrodes placed at the periphery of the wound and changes in the size of the wound and the clinically observed stage of healing.'}], 'secondaryOutcomes': [{'measure': 'Impedance of different wound tissues', 'timeFrame': '3 months', 'description': 'Characteristic impedance of different types of wound tissue'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic foot ulcer'], 'conditions': ['Diabetic Foot Ulcer']}, 'referencesModule': {'references': [{'pmid': '22401341', 'type': 'BACKGROUND', 'citation': 'Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. doi: 10.1177/193229681200600126.'}]}, 'descriptionModule': {'briefSummary': 'The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic patient (Type 1 or 2) with diabetic foot ulcer or lower limb ulcer\n* written informed consent signed\n* insured by the French national health insurance scheme\n\nExclusion Criteria:\n\n* wound in the similar position on the other limb\n* people under legal protection\n* unilateral limb oedema\n* contra-indication to impedancemetry : pregnancy, patient with a pacemaker, neurostimulator or any other implanted electrical device, metallic prostheses\n* patients participating to other protocols involving foot ulcers measurement, if it interfers with the current protocol.'}, 'identificationModule': {'nctId': 'NCT02405767', 'acronym': 'BIPPED', 'briefTitle': 'BioimPEDance of Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'Grenoble University Hospital.'}, 'secondaryIdInfos': [{'id': '2015-A00070-49', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot ulcer impedance', 'description': 'Diabetic patients with a diabetic foot ulcer', 'interventionNames': ['Other: Foot ulcer impedance']}], 'interventions': [{'name': 'Foot ulcer impedance', 'type': 'OTHER', 'description': 'lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).', 'armGroupLabels': ['Foot ulcer impedance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': "Commissariat A L'energie Atomique", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}