Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT07145567
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microangiopathy in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak perfusion in response to local thermal hyperemia', 'timeFrame': 'Investigation will take within 1 day from enrollment.', 'description': 'As measured with investigational devices TCI P4, Pericam LSCI and EPOS devices.'}], 'secondaryOutcomes': [{'measure': 'Perfusion heterogeneity in sole of feet', 'timeFrame': 'Investigation will take place within 1 day from enrollment.', 'description': 'Perfusion heterogeneity index as measured by investigational device TCI P4. It will be stated as a numerical ordinal scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser speckle contrast imaging', 'Spatial frequency domain imaging', 'Laser doppler flowmetry', 'Iontophoresis', 'Local thermal hyperemia', 'Post occlusive reactive hyperemia'], 'conditions': ['Microangiopathy', 'Microvascular Complications']}, 'descriptionModule': {'briefSummary': "This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.", 'detailedDescription': 'This study will employ investigational devices to evaluate microvascular function and correlate it to degree of microangiopathy in persons with diabetes type 1 and healthy controls.\n\nThe investigational device, TCI P4, is a novel, contactless, non-invasive, non-CE marked, class IIa Spatial Frequency Domain Imaging (SFDI) system. The device utilizes an LED light projector to cast patterned, multi-wavelength light onto the skin while multiple cameras capture narrow-band reflections. This method yields two-dimensional data on skin structure and molecular composition (including hemoglobin, oxygen, and water). Established comparators such as laser speckle contrast imaging (LSCI) and the EPOS system are employed to benchmark device performance and validate measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient at Danderyd Hospital Diabetes Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diabetes mellitus type 1.\n* Cohort specific inclusion criteria apply, please review 'groups' section.\n\nExclusion Criteria:\n\n* Patients unable to understand patient information due to cognitive impairment.\n* Patients unable to understand patient information due to language barriers.\n* Ongoing acute infection disease or inflammatory condition.\n* Pregnant or breast-feeding women.\n* Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices."}, 'identificationModule': {'nctId': 'NCT07145567', 'acronym': 'MIND', 'briefTitle': 'Microangiopathy in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Microangiopathy IN Diabetes', 'orgStudyIdInfo': {'id': '2023-02232-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe diabetic microangiopathy', 'description': 'Severe micro-angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. Aged 18-60 years old.'}, {'label': 'Moderate diabetic microangiopathy', 'description': 'Moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure defined as estimated glomerular filtration rate \\<60 mL/min/1.73 m2 body surface, and manifest neuropathy. Aged 18-45 years old.'}, {'label': 'Mild diabetic microangiopathy', 'description': 'Mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy. Aged 18-45 years old.'}, {'label': 'No diabetic microangiopathy', 'description': 'No microangiopathic complications, except for simplex or background retinopathy, which is an early and reversible state. Aged 18-45 years old.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '182 88', 'city': 'Danderyd', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sara Tehrani, Medical Doctor', 'role': 'CONTACT', 'email': 'sara.tehrani@ki.se', 'phone': '+460812355000'}, {'name': 'Jacob Widaeus, Medical Doctor', 'role': 'CONTACT', 'email': 'jacob.widaeus@ki.se', 'phone': '+460812359601'}, {'name': 'Sara Tehrani, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Danderyd University Hospital', 'geoPoint': {'lat': 59.40398, 'lon': 18.02376}}], 'centralContacts': [{'name': 'Sara Tehrani, Medical Doctor', 'role': 'CONTACT', 'email': 'sara.tehrani@ki.se', 'phone': '+46 08 123 550 00'}, {'name': 'Jacob Widaeus, Medical Doctor', 'role': 'CONTACT', 'email': 'jacob.widaeus@ki.se', 'phone': '+46 08 123 596 01'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neko Health AB', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Medical doctor, Specialist in internal medicine', 'investigatorFullName': 'Sara Tehrani', 'investigatorAffiliation': 'Karolinska Institutet'}}}}