Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT02383056
Status:
TERMINATED
Last Update Posted:
2019-05-23
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Knouri@med.miami.edu', 'phone': '305-243-3380', 'title': 'Dr. Keyvan Nouri', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux sham light', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux: 633nm', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA (22.0)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA (22.0)'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA (22.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Days Required for the Wound to Heal Completely', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux sham light'}, {'id': 'OG001', 'title': 'Treatment Group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux: 633nm'}], 'classes': [{'categories': [{'measurements': [{'value': '48.67', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '63.20', 'spread': '12.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '84 days', 'description': 'Assessment by the physician indicating wound closure', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Relative Area of the Surgical Wound Remaining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux sham light'}, {'id': 'OG001', 'title': 'Treatment Group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux: 633nm'}], 'classes': [{'title': 'Week 1 to Week 2', 'categories': [{'measurements': [{'value': '90.80', 'spread': '19.40', 'groupId': 'OG000'}, {'value': '96.0', 'spread': '23.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 to Week 3', 'categories': [{'measurements': [{'value': '60.70', 'spread': '8.71', 'groupId': 'OG000'}, {'value': '77.40', 'spread': '5.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 to Week 4', 'categories': [{'measurements': [{'value': '53.10', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '45.98', 'spread': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4', 'description': 'Initial area \\* ((total area in the evaluated week/total area in the first week) \\* 100) and reported as a percentage (%)', 'unitOfMeasure': 'Percentage of Wound Remaining', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Surface Area of the Surgical Wound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux sham light'}, {'id': 'OG001', 'title': 'Treatment Group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux: 633nm'}], 'classes': [{'title': 'Week 1 to Week 2', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 to Week 3', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 to Week 4', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 to Week 4', 'categories': [{'measurements': [{'value': '-1.38', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4', 'description': 'A blinded investigator manually outlines the wound using a digital planimetry device to measure the surface area in square centimeters.', 'unitOfMeasure': 'Cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux sham light'}, {'id': 'FG001', 'title': 'Treatment Group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux: 633nm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux sham light'}, {'id': 'BG001', 'title': 'Treatment Group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes\n\nOmnilux: 633nm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.3', 'spread': '7.39', 'groupId': 'BG000'}, {'value': '72.6', 'spread': '5.41', 'groupId': 'BG001'}, {'value': '71.0', 'spread': '6.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-12-10', 'size': 100268, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-03T11:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Sufficient enrollment achieved for outcome measures', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2015-02-27', 'resultsFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-02', 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Days Required for the Wound to Heal Completely', 'timeFrame': '84 days', 'description': 'Assessment by the physician indicating wound closure'}], 'secondaryOutcomes': [{'measure': 'Change in Relative Area of the Surgical Wound Remaining', 'timeFrame': 'Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4', 'description': 'Initial area \\* ((total area in the evaluated week/total area in the first week) \\* 100) and reported as a percentage (%)'}, {'measure': 'Change in Total Surface Area of the Surgical Wound', 'timeFrame': 'Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4', 'description': 'A blinded investigator manually outlines the wound using a digital planimetry device to measure the surface area in square centimeters.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wound', 'secondary intention healing', 'lower extremity'], 'conditions': ['Wound']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to evaluate the effectiveness of the light-emitting diode (LED) in promoting healing of the wound on lower leg as a result of surgery. Wounds on the lower leg heal more slowly than wounds on the head and neck; they can also remain deep red for six months to one year. Doctors usually allow a lower leg surgical wound to heal by itself, without stitches or other additional treatment. This is because leg wounds do not hold stitches well and stitches could cause other problems. A major drawback of allowing a surgical wound on the lower leg to heal by itself is the long healing time that can often take months. The investigators wish to evaluate if the LED light treatment of the surgical wound will improve the healing of your wound.\n\nIn order to test if leg wounds heal faster after treatment with LED, half of the patients in the study will receive the LED (Group 2) and half will not receive treatment with LED but will receive a "sham light" treatment (Group 1). Essentially, a sham light treatment refers to regular light (not LED) exposure for 20 minutes. The sham light comes from the same device as the treatment light (Omnilux machine) however, this light has no anticipated effects on wound healing and is used simply to reduce the amount of bias that sometimes complicates the results of these studies. There is no added risk or benefit for the patients in the control group exposed to the sham light. Both groups will receive the standard care of wounds on the lower extremity.', 'detailedDescription': 'Group 2 of this study will receive the LED and half will not receive treatment with LED but will receive a "sham light" treatment (Group 1). Essentially, a sham light treatment refers to regular light (not LED) exposure for 20 minutes. The sham light comes from the same device as the treatment light (Omnilux machine) however, this light has no anticipated effects on wound healing and is used simply to reduce the amount of bias that sometimes complicates the results of these studies. There is no added risk or benefit for the patients in the control group exposed to the sham light. Both groups will receive the standard care of wounds on the lower extremity.\n\nGroups 1 and 2 will receive 4 sham light or treatment sessions, respectively (one session every week for 4 weeks). After these sessions are done, all subjects will continue weekly follow up visits until the wound is closed, or 3 months after the surgery have passed; which ever happens first.\n\nOne final follow up visit will occur 1 week after the wound closed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical defect on the lower extremity left to heal by secondary intention.\n* If women of child bearing potential, contraceptive measures should be used\n* Maximum size of wound is 5cm x5cm; there is no minimum size for the wound.\n\nExclusion Criteria:\n\n* History of porphyria photosensitive eruptions, diabetes mellitus, history of venous insufficiency, known history of peripheral arterial disease (ABI \\<0.8)\n* Use of any ointments or creams containing photosensitizers (coumarins or porphyrins) should be discontinued for 2 weeks prior\n* Use of systemic or local retinoids for the past 6 months.\n* Current pregnancy or breastfeeding\n* History of metastatic cancer.'}, 'identificationModule': {'nctId': 'NCT02383056', 'briefTitle': 'Doubleblinded RCT of the Omnilux on Lower Extremity Surgical Wounds Left to Heal by Second Intention', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Doubleblinded, Randomized, Controlled Trial to Study the Effect of Omnilux Light Emitting Diode on Wound Healing Following Lower Extremity Surgical Wounds Left to Heal by Second Intention', 'orgStudyIdInfo': {'id': '20120475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Group (Group 1)', 'description': 'This group will receive 4 sessions of Omnilux sham light, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes', 'interventionNames': ['Device: Omnilux Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group (Group 2)', 'description': 'This group will receive 4 treatment sessions with Omnilux 633nm LED, starting 1 week after the surgery. Frequency: 1 session every week (+/- 3 days), for 4 weeks. Session duration: 20 minutes', 'interventionNames': ['Device: Omnilux']}], 'interventions': [{'name': 'Omnilux', 'type': 'DEVICE', 'description': 'Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm)', 'armGroupLabels': ['Treatment group (Group 2)']}, {'name': 'Omnilux Sham', 'type': 'DEVICE', 'description': 'Sham light instead of phototherapy from the same light device', 'armGroupLabels': ['Sham Group (Group 1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Keyvan Nouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keyvan Nouri', 'investigatorAffiliation': 'University of Miami'}}}}