Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-25 @ 2:29 AM
Study NCT ID:
NCT02444468
Status:
UNKNOWN
Last Update Posted:
2016-08-18
First Post:
2015-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Treatment of Malleolar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-01', 'releaseDate': '2019-09-10'}], 'estimatedResultsFirstSubmitDate': '2019-09-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001458', 'term': 'Bandages'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from diagnosis-to-surgery', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ankle Fractures', 'Intermittent Pneumatic Compression', 'Comparative Study', 'Preoperative Care']}, 'descriptionModule': {'briefSummary': 'This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling.\n\nThe investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.', 'detailedDescription': 'Malleolar fractures are often complicated by tissue swelling due to soft tissue injury, haemorrhage and secondary inflammation.\n\nThis can lead to severe oedema which can compromise the ability to perform surgery due to blister formation or the inability to close the skin after surgery. Studies have shown that the use of intermittent pneumatic foot-compression (IPC) can reduce waiting time from diagnosis to surgery as well as reduce length of hospital stay.\n\nPurpose of the study is in a randomized study to investigate whether patients requiring surgery because of malleolar fractures has a lower diagnosis-to-surgery time when using IPC than patients not using IPC.\n\nAll patients age 18 or above admitted to our hospital with malleolar fractures (AO type 44-A, 44-B, 44-C) requiring surgery, will be randomized to either in-cast IPC or only cast-immobilization. Time from diagnosis of the fracture(time of the x-ray) until start of surgery(time of incision) will be the primary outcome. Patients will be seen in a postoperative ambulatory follow-up at 14 days, 6 weeks, 3 months and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malleolar fracture requiring surgery.\n\nExclusion Criteria:\n\n* Severe arteriosclerosis.\n* Known or suspected acute DVT or flebit.\n* Severe decompensated heart failure.\n* Pulmonary embolism.\n* Acute skin conditions as dermatitis, infected wounds or recent skintransplant.\n* Open fracture.\n* Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02444468', 'briefTitle': 'Preoperative Treatment of Malleolar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Hospital of Southern Jutland'}, 'officialTitle': 'A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures', 'orgStudyIdInfo': {'id': 'IPC-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPC and bandage', 'description': 'Pneumatic device and bandage', 'interventionNames': ['Device: Flowtron ACS800', 'Other: Bandage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bandage only', 'description': 'Bandage only', 'interventionNames': ['Other: Bandage']}], 'interventions': [{'name': 'Flowtron ACS800', 'type': 'DEVICE', 'description': 'Flowtron ACS800 and bandage', 'armGroupLabels': ['IPC and bandage']}, {'name': 'Bandage', 'type': 'OTHER', 'description': 'Bandage only', 'armGroupLabels': ['Bandage only', 'IPC and bandage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200', 'city': 'Aabenraa', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jesper O Schønnemann, Dr.', 'role': 'CONTACT', 'email': 'jesper.ougaard.schoennemann1@rsyd.dk', 'phone': '+4579976170'}], 'facility': 'Jesper O. Schønnemann', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}], 'centralContacts': [{'name': 'Jesper O Schønnemann, Dr', 'role': 'CONTACT', 'email': 'jesper.ougaard.schoennemann1@rsyd.dk', 'phone': '+4579976170'}], 'overallOfficials': [{'name': 'Jesper O Schønnemann, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital southern Jutland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital of Southern Jutland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-10', 'type': 'RELEASE'}, {'date': '2019-10-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hospital of Southern Jutland'}}}}