Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-04 @ 5:35 AM
Study NCT ID:
NCT00426166
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2007-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment Of Infrared Photobiotherapy for Improved Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martin.skie@utoledo.edu', 'phone': '419-383-3515', 'title': 'Dr. Martin Skie', 'organization': 'University of Toledo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of surgery to 12 weeks post op.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FACES Pain Rating Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.3', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (2 weeks after surgery)', 'description': 'The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FACES Pain Rating Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy Group', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after surgery', 'description': 'The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FACES Pain Rating Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy Group', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'comment': 'Please note: Study results/data destroyed and not available to report outcome measures due to 3 year minimum record retention.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.5', 'comment': 'Please note: Study results/data destroyed and not available to report outcome measures due to 3 year minimum record retention.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after surgery', 'description': 'The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Bodily Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (2 weeks after surgery)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units in a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Bodily Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy Group', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '44', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Bodily Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '52', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '54', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '58', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '55', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '52', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '70', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '63', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '58', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '71', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '60', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '40', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '84', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '36-Item Short Form Survey - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Level Laser Therapy', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'OG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '74', 'comment': 'All data related to the study has been destroyed. Only data available is means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Level Laser Therapy Group', 'description': 'Low Level Laser Therapy: 7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.'}, {'id': 'FG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Per the initial IRB application, the criteria for selection and exclusion was based on the following:\n\nInclusion - Adult patients with unhealed wounds of the upper extremity.\n\nFor Outcome Measures, study results were destroyed/shredded based on 3 year minimum record retention after completion of research. Not able to provide patient reported ranges. Only data available is means.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Level Laser Therapy Group', 'description': 'Low Level Laser Therapy: Low Level Laser Therapy on Wound'}, {'id': 'BG001', 'title': 'Standard Treatment Control Group', 'description': 'No Laser Therapy. Outcome Measures the same.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown gender', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2007-01-22', 'resultsFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2007-01-23', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-16', 'studyFirstPostDateStruct': {'date': '2007-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FACES Pain Rating Scale Scores', 'timeFrame': 'baseline (2 weeks after surgery)', 'description': 'The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.'}, {'measure': 'FACES Pain Rating Scale Scores', 'timeFrame': '6 weeks after surgery', 'description': 'The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.'}, {'measure': 'FACES Pain Rating Scale.', 'timeFrame': '12 weeks after surgery', 'description': 'The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.'}], 'secondaryOutcomes': [{'measure': '36-Item Short Form Survey - Bodily Pain Scores', 'timeFrame': 'baseline (2 weeks after surgery)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Bodily Pain Scores', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Bodily Pain Scale', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - General Health', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - General Health', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - General Health', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Physical Function', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Physical Function', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Physical Function', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Mental Health', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Mental Health', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Mental Health', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Social Function', 'timeFrame': '2 weeks after surgery (baseline)', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Social Function', 'timeFrame': '6 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}, {'measure': '36-Item Short Form Survey - Social Function', 'timeFrame': '12 weeks after surgery', 'description': 'Response to questions generates a numerical score, with a higher score representing a better outcome.\n\nMeasures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.'}]}, 'conditionsModule': {'conditions': ['Wound Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).', 'detailedDescription': 'This is a prospective, two group, controlled study using random assignment. All eligible patients will be randomly assigned to one of two groups: the control group (usual care) or the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study: 25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group.\n\nAll subjects will be recruited within one to two days prior to hospital discharge or at the time of their first postoperative clinic visit. No subjects will be recruited while sedated or receiving intravenous pain medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 and \\< 85 years\n* Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)\n* Currently resides within 100 miles of UMC\n\nExclusion Criteria:\n\n* Pregnant\n* Pacemaker\n* Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)\n* Two or more cardiac risk factors\n* Intraoperative complications\n* Wound infection\n* Open Wound'}, 'identificationModule': {'nctId': 'NCT00426166', 'briefTitle': 'Assessment Of Infrared Photobiotherapy for Improved Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'University of Toledo'}, 'officialTitle': 'Assessment of Infrared Photobiotherapy for Improved Wound Healing', 'orgStudyIdInfo': {'id': 'Wound Healing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Low Level Laser Therapy', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'No Laser Therapy. Outcome Measures the same.'}], 'interventions': [{'name': 'Low Level Laser Therapy', 'type': 'DEVICE', 'description': '7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo, Health Science Campus', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Martin Skie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toledo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toledo Health Science Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martin Skie, MD', 'investigatorAffiliation': 'University of Toledo Health Science Campus'}}}}