Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02295020
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vdasa@lsuhsc.edu', 'phone': '(504) 412-1700', 'title': 'Dr. Vinod Dasa', 'organization': 'LSUHSC-NO -Orthopaedic Department'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Group A will receive standard treatment only\n\nStandard treatment: Standard treatment such as NSAIDs and injections', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Group B will receive standard treatment and the Bioskin Ten-7 knee brace.\n\nStandard treatment: Standard treatment such as NSAIDs and injections\n\nStandard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'CVA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'KOOS - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections.'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '26.8'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '18.0'}]}]}], 'analyses': [{'pValue': '0.181', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8- Day 0', 'description': 'Value at 8 weeks - value at day 0', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.'}, {'type': 'PRIMARY', 'title': 'KOOS - Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only.', 'description': 'Standard treatment only such as NSAIDs and injections.'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '19.5'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '-5.4', 'upperLimit': '11.8'}]}]}], 'analyses': [{'pValue': '0.232', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8 - Day 0', 'description': 'Value at 8 weeks - value at day 0', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.'}, {'type': 'PRIMARY', 'title': 'KOOS - ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '23.2'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '17.4'}]}]}], 'analyses': [{'pValue': '0.311', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 8 - day 0', 'description': 'Value at 8 weeks - value at day 0', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.'}, {'type': 'PRIMARY', 'title': 'KOOS - Sport/Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '31.0'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '-7.6', 'upperLimit': '26.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8 - day 0', 'description': 'Value at 8 weeks - value at day 0', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.'}, {'type': 'PRIMARY', 'title': 'KOOS - QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '21.8'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '15.6'}]}]}], 'analyses': [{'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8 - day 0', 'description': 'Value at 8 weeks - value at day 0', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.'}, {'type': 'PRIMARY', 'title': 'Synovial Fluid Analysis (IL-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections.'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace'}], 'classes': [{'categories': [{'measurements': [{'value': '-453.8', 'groupId': 'OG000', 'lowerLimit': '-19670', 'upperLimit': '18168'}, {'value': '-1055', 'groupId': 'OG001', 'lowerLimit': '-7483', 'upperLimit': '10399'}]}]}], 'analyses': [{'pValue': '0.860', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8 - day 0', 'description': 'Interleukine 6 in Synovial fluid analysis', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.'}, {'type': 'PRIMARY', 'title': 'Synovial Fluid Analysis (IL-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus knee Bioskin Ten-7 knee brace'}], 'classes': [{'categories': [{'measurements': [{'value': '-379.8', 'groupId': 'OG000', 'lowerLimit': '-2875', 'upperLimit': '6878'}, {'value': '-488.9', 'groupId': 'OG001', 'lowerLimit': '-3542', 'upperLimit': '4906'}]}]}], 'analyses': [{'pValue': '0.735', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8 - day 0', 'description': 'Interleukine 8 in Synovial fluid analysis', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.'}, {'type': 'PRIMARY', 'title': 'Synovial Fluid Analysis (TNF-alpha)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace'}], 'classes': [{'categories': [{'measurements': [{'value': '-97.4', 'groupId': 'OG000', 'lowerLimit': '-242.3', 'upperLimit': '172.4'}, {'value': '-51.7', 'groupId': 'OG001', 'lowerLimit': '-430.0', 'upperLimit': '280.9'}]}]}], 'analyses': [{'pValue': '0.479', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8 - day 0', 'description': 'Tumor necrosis factor - alpha in Synovial fluid analysis', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.'}, {'type': 'PRIMARY', 'title': 'Synovial Fluid Analysis (MIP - 1alpha)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.'}], 'classes': [{'categories': [{'measurements': [{'value': '-246.7', 'groupId': 'OG000', 'lowerLimit': '-821.2', 'upperLimit': '575.2'}, {'value': '-49.8', 'groupId': 'OG001', 'lowerLimit': '-756.6', 'upperLimit': '1715'}]}]}], 'analyses': [{'pValue': '0.323', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8 - day 0', 'description': 'Macrophage Inflammatory Proteins - 1alpha', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.'}, {'type': 'PRIMARY', 'title': 'Synovial Fluid Analysis (MCP - 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace'}], 'classes': [{'categories': [{'measurements': [{'value': '-7170', 'groupId': 'OG000', 'lowerLimit': '-14933', 'upperLimit': '17960'}, {'value': '-4890', 'groupId': 'OG001', 'lowerLimit': '-15989', 'upperLimit': '17432'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 8 -day 0', 'description': 'Monocyte chemotactic protein-1 - 1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.'}, {'type': 'PRIMARY', 'title': 'Oxford Knee Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Group A will receive standard treatment only\n\nStandard treatment: Standard treatment such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Group B will receive standard treatment and the Bioskin Ten-7 knee brace.\n\nStandard treatment: Standard treatment such as NSAIDs and injections\n\nStandard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace'}], 'timeFrame': 'Day 0 and Week 8', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome was not measured as KOOS was measured as the only patient reported outcome.'}, {'type': 'PRIMARY', 'title': 'WOMAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Group A will receive standard treatment only\n\nStandard treatment: Standard treatment such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Group B will receive standard treatment and the Bioskin Ten-7 knee brace.\n\nStandard treatment: Standard treatment such as NSAIDs and injections\n\nStandard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace'}], 'timeFrame': 'Day 0 and Week 8', 'description': 'assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome was not measured as KOOS was measured as the only patient reported outcome.'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Group A will receive standard treatment only\n\nStandard treatment: Standard treatment such as NSAIDs and injections'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Group B will receive standard treatment and the Bioskin Ten-7 knee brace.\n\nStandard treatment: Standard treatment such as NSAIDs and injections\n\nStandard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace'}], 'timeFrame': 'Day 0 and Week 8', 'description': 'identifies pain level', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome was not measured as KOOS was measured as the only patient reported outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Treatment Only.', 'description': 'Group A will receive standard treatment only\n\nStandard treatment: Standard treatment such as NSAIDs and injections'}, {'id': 'FG001', 'title': 'Standard Treatment Plus Bioskin Ten-7.', 'description': 'Group B will receive standard treatment and the Bioskin Ten-7 knee brace.\n\nStandard treatment: Standard treatment such as NSAIDs and injections\n\nStandard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Treatment Only', 'description': 'Standard treatment only such as NSAIDs and injections'}, {'id': 'BG001', 'title': 'Standard Treatment Plus Bioskin Ten-7 Knee Brace', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Standard of care', 'classes': [{'title': 'Surpatz', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'NSAID', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Medications', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KOOS - Pain', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '18.7', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '20.3', 'groupId': 'BG001'}, {'value': '35.6', 'spread': '19.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KOOS = Knee injury and Osteoarthritis Outcome Score. Pain refers to the pain sub-score.The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KOOS - Symptoms', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '22.4', 'groupId': 'BG000'}, {'value': '35.6', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '40.4', 'spread': '20.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KOOS = Knee injury and Osteoarthritis Outcome Score. Symptoms refers to the Symptoms sub-score.The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KOOS - ADL', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '22.2', 'groupId': 'BG001'}, {'value': '39.0', 'spread': '19.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KOOS = Knee injury and Osteoarthritis Outcome Score. ADL refers to the activities of daily living sub-score. The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KOOS - Sport/Rec', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '25.9', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '22.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KOOS = Knee injury and Osteoarthritis Outcome Score. Sport/Rec refers to the sport and recreational activities sub-score. The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KOOS - QOL', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '19.6', 'groupId': 'BG000'}, {'value': '14.4', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '20.9', 'spread': '18.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'KOOS = Knee injury and Osteoarthritis Outcome Score. QOL refers to the quality of life sub-score. The scale is 0 to 100 where 100 indicates no problems and 0 indicates extreme problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IL-6', 'classes': [{'categories': [{'measurements': [{'value': '1639', 'groupId': 'BG000', 'lowerLimit': '49.9', 'upperLimit': '25426'}, {'value': '1309', 'groupId': 'BG001', 'lowerLimit': '9.2', 'upperLimit': '7905'}, {'value': '1467.1', 'groupId': 'BG002', 'lowerLimit': '9.2', 'upperLimit': '25426'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'IL-8', 'classes': [{'categories': [{'measurements': [{'value': '653.3', 'groupId': 'BG000', 'lowerLimit': '19.2', 'upperLimit': '4043'}, {'value': '486.5', 'groupId': 'BG001', 'lowerLimit': '8.9', 'upperLimit': '7802'}, {'value': '643.0', 'groupId': 'BG002', 'lowerLimit': '8.9', 'upperLimit': '7802'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'TNF-alpha', 'classes': [{'categories': [{'measurements': [{'value': '108.1', 'groupId': 'BG000', 'lowerLimit': '7.7', 'upperLimit': '1079'}, {'value': '104.8', 'groupId': 'BG001', 'lowerLimit': '2.1', 'upperLimit': '436.8'}, {'value': '108.1', 'groupId': 'BG002', 'lowerLimit': '2.1', 'upperLimit': '1079'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'MIP-1alpha', 'classes': [{'categories': [{'measurements': [{'value': '255.5', 'groupId': 'BG000', 'lowerLimit': '1.2', 'upperLimit': '24590'}, {'value': '162.2', 'groupId': 'BG001', 'lowerLimit': '4.2', 'upperLimit': '2069'}, {'value': '250.8', 'groupId': 'BG002', 'lowerLimit': '1.2', 'upperLimit': '24590'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'MCP-1', 'classes': [{'categories': [{'measurements': [{'value': '8664', 'groupId': 'BG000', 'lowerLimit': '1233', 'upperLimit': '24831'}, {'value': '10944', 'groupId': 'BG001', 'lowerLimit': '876.7', 'upperLimit': '21443'}, {'value': '10188', 'groupId': 'BG002', 'lowerLimit': '876.7', 'upperLimit': '24831'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2014-11-17', 'resultsFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2014-11-18', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-01', 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS - Pain', 'timeFrame': 'Week 8- Day 0', 'description': 'Value at 8 weeks - value at day 0'}, {'measure': 'KOOS - Symptoms', 'timeFrame': 'Week 8 - Day 0', 'description': 'Value at 8 weeks - value at day 0'}, {'measure': 'KOOS - ADL', 'timeFrame': 'week 8 - day 0', 'description': 'Value at 8 weeks - value at day 0'}, {'measure': 'KOOS - Sport/Rec', 'timeFrame': 'Week 8 - day 0', 'description': 'Value at 8 weeks - value at day 0'}, {'measure': 'KOOS - QOL', 'timeFrame': 'Week 8 - day 0', 'description': 'Value at 8 weeks - value at day 0'}, {'measure': 'Synovial Fluid Analysis (IL-6)', 'timeFrame': 'Week 8 - day 0', 'description': 'Interleukine 6 in Synovial fluid analysis'}, {'measure': 'Synovial Fluid Analysis (IL-8)', 'timeFrame': 'Week 8 - day 0', 'description': 'Interleukine 8 in Synovial fluid analysis'}, {'measure': 'Synovial Fluid Analysis (TNF-alpha)', 'timeFrame': 'Week 8 - day 0', 'description': 'Tumor necrosis factor - alpha in Synovial fluid analysis'}, {'measure': 'Synovial Fluid Analysis (MIP - 1alpha)', 'timeFrame': 'Week 8 - day 0', 'description': 'Macrophage Inflammatory Proteins - 1alpha'}, {'measure': 'Synovial Fluid Analysis (MCP - 1)', 'timeFrame': 'Week 8 -day 0', 'description': 'Monocyte chemotactic protein-1 - 1'}, {'measure': 'Oxford Knee Score', 'timeFrame': 'Day 0 and Week 8'}, {'measure': 'WOMAC', 'timeFrame': 'Day 0 and Week 8', 'description': 'assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Day 0 and Week 8', 'description': 'identifies pain level'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.', 'detailedDescription': "Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.\n* Must have telephone access.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02295020', 'acronym': 'Bioskin', 'briefTitle': 'Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cropper Medical'}, 'officialTitle': 'Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.', 'orgStudyIdInfo': {'id': '8627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Treatment Only', 'description': 'Group A will receive standard treatment only such as NSAIDs and injections', 'interventionNames': ['Drug: Standard treatment only']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Treatment plus Bioskin Ten-7', 'description': 'Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.', 'interventionNames': ['Drug: Standard treatment only', 'Device: Standard treatment plus Bioskin Ten-7 knee brace']}], 'interventions': [{'name': 'Standard treatment only', 'type': 'DRUG', 'otherNames': ['NSAIDs and injections'], 'description': 'Standard treatment such as NSAIDs and injections', 'armGroupLabels': ['Standard Treatment Only', 'Standard Treatment plus Bioskin Ten-7']}, {'name': 'Standard treatment plus Bioskin Ten-7 knee brace', 'type': 'DEVICE', 'description': 'Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.', 'armGroupLabels': ['Standard Treatment plus Bioskin Ten-7']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vinod Dasa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LSUHSC-NO, Orthopaedic Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cropper Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}