Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT00616668
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2008-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-14', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-14', 'lastUpdatePostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.', 'timeFrame': '1-4 month'}, {'measure': 'The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.', 'timeFrame': '2-6 month'}], 'secondaryOutcomes': [{'measure': 'The duration of stump healing and functional status of transtibial amputees.', 'timeFrame': '1-6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transtibial amputees due to vascular diseases.'], 'conditions': ['Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.', 'detailedDescription': "The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis.\n\nIn spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Transtibial amputees due to vascular diseases.\n\nExclusion Criteria:\n\n* Bilateral amputation.\n* Upper extremity can't bear weight.\n* The sound leg can't bear weight.\n* Amputee that needs Dialysis treatment.\n* Cognitive impairment."}, 'identificationModule': {'nctId': 'NCT00616668', 'briefTitle': 'Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees', 'orgStudyIdInfo': {'id': 'SHEBA-07-2718-AK-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Air- Limb', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Itzhak Siev- Ner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}}}}