Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT06438133
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edema reduction', 'timeFrame': '14 days', 'description': 'Assessed by Cimon sensor (in capacitans, pF)'}], 'secondaryOutcomes': [{'measure': 'Edema reduction', 'timeFrame': '14 days', 'description': 'Assessed by tape measurement (in cm), converted to volume by formula of truncated cone'}, {'measure': 'Edema reduction', 'timeFrame': '14 days', 'description': 'Assessed by perometry (in ml)'}, {'measure': 'Edema reduction', 'timeFrame': '14 days', 'description': 'Assessed by Dual energy X-ray Absorptiometry (in kg)'}, {'measure': 'Symptoms related to chronic edema', 'timeFrame': '14 days', 'description': 'Self-reported pain, tension and heaviness'}, {'measure': 'Physical Activity (PA)', 'timeFrame': '14 days', 'description': 'Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes)'}, {'measure': 'Adverse events', 'timeFrame': '14 days', 'description': 'Any adverse events related to compression bandaging and the application of sensors'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Compression therapy', 'Compression bandaging', 'Chronic edema', 'Psychometrics'], 'conditions': ['Compression; Vein', 'Venous Insufficiency', 'Lymphedema of Leg', 'Digital Technology']}, 'descriptionModule': {'briefSummary': 'Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days.', 'detailedDescription': 'The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging.\n\nThe study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic edema of the lower limb\n* Referred to compression bandaging\n* Circumference of widest point of the lower leg between 35-75 cm\n\nExclusion Criteria:\n\n* Wounds at the lower leg (at the widest circumference of the lower leg)\n* Acute deep venous thrombosis in the leg\n* Untreated cellulitis\n* Severe heart- or kidneyfailure\n* Severe peripheral neuropathy in the lower limbs'}, 'identificationModule': {'nctId': 'NCT06438133', 'acronym': 'CIMON', 'briefTitle': 'Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Digital Supported Compression Bandaging in Patients with Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor', 'orgStudyIdInfo': {'id': 'CIMON'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chronic edema of the lower limbs', 'description': 'Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.', 'interventionNames': ['Other: CIMON', 'Other: Sens Motion']}], 'interventions': [{'name': 'CIMON', 'type': 'OTHER', 'description': 'The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied.', 'armGroupLabels': ['Patients with chronic edema of the lower limbs']}, {'name': 'Sens Motion', 'type': 'OTHER', 'description': 'The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps.', 'armGroupLabels': ['Patients with chronic edema of the lower limbs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bispebjerg', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mette L Joergensen, RN', 'role': 'CONTACT'}], 'facility': 'Department of Dermatology, Frederiksberg Bispebjerg Hospital', 'geoPoint': {'lat': 55.71017, 'lon': 12.53147}}, {'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jan Christensen, Phd', 'role': 'CONTACT'}], 'facility': 'Department of Physiotherapy and Occupational Therapy, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Merete C Wittenkamp, MPH', 'role': 'CONTACT', 'email': 'merete.celano.wittenkamp@regionh.dk', 'phone': '+4593911784'}], 'facility': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Hvidovre', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kira Marie Milandt Skibdal, Msc', 'role': 'CONTACT'}], 'facility': 'Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Odense', 'state': 'Region Syddanmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Marianne Holt, Msc', 'role': 'CONTACT'}], 'facility': 'Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Merete Celano Wittenkamp, MPH', 'role': 'CONTACT', 'email': 'merete.celano.wittenkamp@regionh.dk', 'phone': '+004593911784'}, {'name': 'Carsten Bogh Juhl, Professor', 'role': 'CONTACT', 'email': 'carsten.bogh.juhl@regionh.dk'}], 'overallOfficials': [{'name': 'Carsten Bogh Juhl, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Herlev and Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carsten Bogh Juhl', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carsten Bogh Juhl', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}