Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-21 @ 2:20 PM
Study NCT ID:
NCT02810002
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001768', 'term': 'Blister'}, {'id': 'D015775', 'term': 'Fractures, Stress'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-19', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-19', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of recruits with at least one injury related to the boots', 'timeFrame': '14 weeks', 'description': 'Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blister', 'Abrasion', 'Stress Fracture', 'Ankle Sprain', 'Patellofemoral Pain Syndrome', 'Back Pain']}, 'referencesModule': {'references': [{'pmid': '28265448', 'type': 'DERIVED', 'citation': 'Milgrom C, Sorkin A, Gam A, Singer J, Nir I, Kogan B, Finestone AS. The search for the best infantry boot. Disaster Mil Med. 2016 Oct 10;2:14. doi: 10.1186/s40696-016-0024-5. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'One hundred infantry recruits will be randomly assigned to two groups. Injuries will be monitored.', 'detailedDescription': 'One hundred infantry recruits will be randomly assigned to receive experimental infantry boots (DEFINITE-REGULATOR) or standard issued boots (modified Belleville 390 TROP).\n\nOveruse injuries and foot injuries will be monitored over a period of 14 weeks. The intervention group will wear experimental infantry boots and the controls will wear standard issue boots.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infantry recruits on selected base\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02810002', 'briefTitle': 'Assessing Foot Injuries in Infantry Recruits Wearing Different Boots', 'organization': {'class': 'OTHER', 'fullName': 'Medical Corps, Israel Defense Force'}, 'officialTitle': 'Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'IDF-1346-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEFINITE-REGULATOR', 'description': 'Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel', 'interventionNames': ['Device: Experimental infantry boot - DEFINITE-REGULATOR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'modified Belleville 390 TROP', 'description': 'Standard issue infantry boot', 'interventionNames': ['Device: Control infantry boot']}], 'interventions': [{'name': 'Experimental infantry boot - DEFINITE-REGULATOR', 'type': 'DEVICE', 'description': 'Training: infantry basic training in the experimental boots', 'armGroupLabels': ['DEFINITE-REGULATOR']}, {'name': 'Control infantry boot', 'type': 'DEVICE', 'description': 'Training: infantry basic training in the control boots', 'armGroupLabels': ['modified Belleville 390 TROP']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Raw unidentified data available by contacting the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Corps, Israel Defense Force', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}