Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT00304733
Status:
UNKNOWN
Last Update Posted:
2006-03-20
First Post:
2006-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-08', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2006-03-16', 'studyFirstSubmitDate': '2006-03-16', 'studyFirstSubmitQcDate': '2006-03-16', 'lastUpdatePostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound surface area reduction'}], 'secondaryOutcomes': [{'measure': 'time to wound healing (days)'}]}, 'conditionsModule': {'keywords': ['neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading'], 'conditions': ['Neuropathic Foot Ulceration in Individuals With Diabetes']}, 'descriptionModule': {'briefSummary': 'Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes', 'detailedDescription': 'In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diabetes\n* neuropathic ulcer grade 1/2 (wagner scale)\n* confirmed sensory neuropathy\n\nExclusion Criteria:\n\n* osteomyelitis patients unable to walk\n* life threatening co-morbidity ankle/brachial index , 0.4'}, 'identificationModule': {'nctId': 'NCT00304733', 'briefTitle': 'Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration', 'organization': {'class': 'OTHER', 'fullName': 'Rehabilitation Centre Amsterdam'}, 'officialTitle': 'Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration', 'orgStudyIdInfo': {'id': '2024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cast vs. shoe', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090 hm', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'f. b. van de weg, m.d.', 'role': 'STUDY_CHAIR', 'affiliation': 'rehabiliation centre amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rehabilitation Centre Amsterdam', 'class': 'OTHER'}, 'collaborators': [{'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, {'name': 'Ontwikkelingsfonds Orthopedisch maatschoeisel', 'class': 'UNKNOWN'}]}}}