Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT02986256
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2016-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D016523', 'term': 'Foot Ulcer'}], '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': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hospitalization days related to diabetic foot ulcers after one year of follow-up', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Total direct care costs between the Telepied group and the control group', 'timeFrame': '12 months', 'description': 'hospitalization costs, transport costs, nursing costs, liberal nursing costs, material costs, number of consultations with the doctor'}, {'measure': 'Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group', 'timeFrame': '12 months'}, {'measure': 'Ulcer recidivism rate in the Telepied group versus control group.', 'timeFrame': '12 months'}, {'measure': 'Frequency of ulceration', 'timeFrame': '12 months'}, {'measure': 'Duration of ulceration', 'timeFrame': '12 months'}, {'measure': 'Healing rate between the Telepied group and the control group', 'timeFrame': '12 months'}, {'measure': 'Amputation rate between the two groups', 'timeFrame': '12 months'}, {'measure': 'Patient satisfaction score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['telemedicine'], 'conditions': ['Diabetes Mellitus', 'Ulcer Foot']}, 'descriptionModule': {'briefSummary': 'The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.\n\nIt is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.\n\nPatients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.\n\nThe patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.\n\nEvery patients will be followed for one year (12 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years\n* Diabetic patients with foot ulcer\n* Patient who agreed to participate in the study and sign free and informed consent\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Pregnant Woman\n* Patient deprived of liberty by a judicial or administrative decision or a person subject to a legal protection measure\n* Patient already involved in another clinical trial protocol'}, 'identificationModule': {'nctId': 'NCT02986256', 'acronym': 'TELEPIED', 'briefTitle': 'Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète"}, 'officialTitle': 'Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients', 'orgStudyIdInfo': {'id': '2016-A01136-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventionnal Group', 'description': 'No intervention for this group. Patients will be followed by a usual care.'}, {'type': 'EXPERIMENTAL', 'label': '"Telepied" Group', 'description': 'Patients will be followed by a nurse referring to ulcers of the diabetic foot.', 'interventionNames': ['Behavioral: Taking pictures', 'Behavioral: Visit at home']}], 'interventions': [{'name': 'Taking pictures', 'type': 'BEHAVIORAL', 'description': 'Photograph of foot ulcer with transmission to referring nurse 1 time per week', 'armGroupLabels': ['"Telepied" Group']}, {'name': 'Visit at home', 'type': 'BEHAVIORAL', 'description': 'Home visit by the referring nurse every 15 days', 'armGroupLabels': ['"Telepied" Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud-Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'overallOfficials': [{'name': 'Dured Dardari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}