Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-27 @ 11:48 AM
Study NCT ID:
NCT01590758
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C093828', 'term': 'pexiganan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'delucciarj@gmail.com', 'phone': '+19145226503', 'title': 'Robert J DeLuccia', 'organization': 'Dipexium Pharmaceuticals, Inc'}, 'certainAgreement': {'otherDetails': 'If no multi-site publication within 18 months of study completion, Site shall have right to publish subject to: 1) Prior to submitting/presenting, Site shall provide Sponsor a copy; Sponsor shall have 60 days to review/comment. 2) Site shall remove any Confidential Information prior to submitting/presenting the materials. 3) Site shall further delay publication/presentation for up to 120 days to allow Sponsor to protect its interests in any Sponsor Inventions described in any such materials.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Topical Pexiganan Cream 0.8%', 'description': 'Topical pexiganan cream 0.8%: 14 days of treatment', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 6, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Topical Placebo Control', 'description': 'Topical placebo cream: 14 days of treatment', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 4, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diabetes inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Pexiganan Cream 0.8%', 'description': 'Topical pexiganan cream 0.8%: 14 days of treatment'}, {'id': 'OG001', 'title': 'Topical Placebo Control', 'description': 'Topical placebo cream: 14 days of treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'The numbers of participants with Clinical Response, defined as resolution of infection, are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Microbiological Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Pexiganan Cream 0.8%', 'description': 'Topical pexiganan cream 0.8%: 14 days of treatment'}, {'id': 'OG001', 'title': 'Topical Placebo Control', 'description': 'Topical placebo cream: 14 days of treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Microbiological (positive for baseline pathogens)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Pexiganan Cream 0.8%', 'description': 'Topical pexiganan cream 0.8%: 14 days of treatment'}, {'id': 'OG001', 'title': 'Topical Placebo Control', 'description': 'Topical placebo cream: 14 days of treatment'}], 'classes': [{'title': 'Incidence of any TEAE', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Incidence of Serious TEAE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'The numbers of participants with TEAEs, including those with Serious TEAEs, are reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Pexiganan Cream 0.8%', 'description': 'Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)\n\nStandard wound care: 28-day trial period'}, {'id': 'FG001', 'title': 'Topical Placebo Control', 'description': 'Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)\n\nStandard wound care: 28-day trial period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects recruited at outpatient clinics and practices', 'preAssignmentDetails': 'No wash-out or run-in periods; eligible subjects were immediately assigned to treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Pexiganan Cream 0.8%', 'description': 'Topical pexiganan cream 0.8%: 14 days of treatment\n\nStandard wound care: 28-day trial period'}, {'id': 'BG001', 'title': 'Topical Placebo Control', 'description': 'Topical placebo cream: 14 days of treatment\n\nStandard wound care: 28-day trial period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '59.22', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '58.42', 'spread': '10.97', 'groupId': 'BG001'}, {'value': '58.78', 'spread': '10.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '98', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '146', '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': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Wound surface area', 'classes': [{'categories': [{'title': '<1 sq cm', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '1 - <2 sq cm', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': '>=2 sq cm', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2012-04-27', 'resultsFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-19', 'studyFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Response', 'timeFrame': '28 days', 'description': 'The numbers of participants with Clinical Response, defined as resolution of infection, are reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Microbiological Success', 'timeFrame': '28 days', 'description': 'The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAE)', 'timeFrame': '28 days', 'description': 'The numbers of participants with TEAEs, including those with Serious TEAEs, are reported'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic Foot Ulcer Infection'], 'conditions': ['Diabetic Foot Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetes mellitus.\n2. Male or female at least 18 years old.\n3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.\n4. Subject is to be treated on an outpatient basis.\n5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.\n6. Localized mild infection of the ulcer.\n7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.\n8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.\n\nExclusion Criteria:\n\n1. IDSA-defined moderate infection.\n2. IDSA-defined severe infection.\n3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.\n4. \\> 1 infected foot ulcer.\n5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.\n6. Subject has received a systemic antibiotic within 48 hours prior to Screening.\n7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.\n8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.\n9. Clinically significant peripheral arterial disease requiring vascular intervention.\n10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.'}, 'identificationModule': {'nctId': 'NCT01590758', 'acronym': 'OneStep-1', 'briefTitle': 'Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dipexium Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'DPX-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Topical placebo control', 'interventionNames': ['Drug: Topical placebo cream', 'Other: Standard wound care']}, {'type': 'EXPERIMENTAL', 'label': 'Topical pexiganan cream 0.8%', 'interventionNames': ['Drug: Topical pexiganan cream 0.8%', 'Other: Standard wound care']}], 'interventions': [{'name': 'Topical pexiganan cream 0.8%', 'type': 'DRUG', 'otherNames': ['MSI-78'], 'description': '14 days of treatment', 'armGroupLabels': ['Topical pexiganan cream 0.8%']}, {'name': 'Topical placebo cream', 'type': 'DRUG', 'description': '14 days of treatment', 'armGroupLabels': ['Topical placebo control']}, {'name': 'Standard wound care', 'type': 'OTHER', 'description': '14 days of treatment', 'armGroupLabels': ['Topical pexiganan cream 0.8%', 'Topical placebo control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Emerson', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.97621, 'lon': -74.02625}}, {'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Aiken', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.56042, 'lon': -81.71955}}, {'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Michael H. Silverman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioStrategics Consulting Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dipexium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}