Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-04 @ 11:14 PM
Study NCT ID:
NCT03232333
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MIRODERM H2H DFU Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmacenski@miromatrix.com', 'phone': '952.942-6000', 'title': 'Head of Clinical Affairs', 'organization': 'Miromatrix'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Not a randomized trial'}}, 'adverseEventsModule': {'timeFrame': '12 Months', 'eventGroups': [{'id': 'EG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 11, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in wound size', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '57.89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with healed ulcers within 12 weeks of treatment', 'unitOfMeasure': 'Percentage of participants with healed u', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MIRODERM Applications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Frequency of MIRODERM applications prior to wound closing', 'unitOfMeasure': 'Applications', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Measures the time from treatment to wound healing', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who healed in 12 weeks or less'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change in Patient's Wound Size", 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Gives the mean area that the wound closed per week', 'unitOfMeasure': 'cm^2 per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Short Form F36 - Physical Component Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '39.0', 'spread': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '37.0', 'spread': '25.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.71', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)', 'description': "Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects who's ulcer healed in 12 weeks or less two without appropriate data"}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Short Form 36 - Mental Component Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '71.0', 'spread': '16.9', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '71.9', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.63', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)', 'description': "Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Subjects who's wound healed in 12 weeks or less one without appropriate data"}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Short Form - 36: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'classes': [{'title': 'Pre-procedure', 'categories': [{'measurements': [{'value': '57.5', 'spread': '32.2', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '61.9', 'spread': '29.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.01', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)', 'description': "Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Infection or Osteomyelitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MIRODERM', 'description': 'Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61.7', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '8 are hispanic'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ankle Brachial Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Ankle Bronchial Index (ABI) is the systolic blood pressure reading obtained at the ankle divided by the systolic blood pressure reading from an arm. An ABI of 0.9 or may indicate peripheral vascular insufficiency. An ABI ratio between 1.0 and 1.4 is normal', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tobacco Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': '< 1 pack/day', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '> 1 pack/day', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Occasional', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Monthly', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Weekly', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Daily', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Wound Size Screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wound Size Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wound Age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '27.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior Treatments', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Applications', 'dispersionType': 'FULL_RANGE'}, {'title': 'Wound Location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Toes', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Forefoot', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Midfoot', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Heel', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-13', 'size': 607831, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-11T11:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Debridement waste'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2017-07-25', 'resultsFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-17', 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MIRODERM Applications', 'timeFrame': '12 weeks', 'description': 'Frequency of MIRODERM applications prior to wound closing'}, {'measure': 'Time to Closure', 'timeFrame': '12 weeks', 'description': 'Measures the time from treatment to wound healing'}, {'measure': "Change in Patient's Wound Size", 'timeFrame': '12 weeks', 'description': 'Gives the mean area that the wound closed per week'}, {'measure': 'Short Form F36 - Physical Component Summary Score', 'timeFrame': 'Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)', 'description': "Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100."}, {'measure': 'Short Form 36 - Mental Component Summary Score', 'timeFrame': 'Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)', 'description': "Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100."}, {'measure': 'Short Form - 36: Bodily Pain', 'timeFrame': 'Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)', 'description': "Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100."}], 'primaryOutcomes': [{'measure': 'Percentage of Participants', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with healed ulcers within 12 weeks of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.', 'detailedDescription': 'The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life.\n\nThe primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%.\n\nThis is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history.\n\nOutcome assessments:\n\n* proportion of subjects with 100% epithelialization of wound\n* SF-36\n* Adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have at least one small to moderately sized diabetic foot ulcer and have been undergoing extended and unsuccessful treatment, as defined by failure of the wound to completely close over the previous 3 months and after application of at least 2 biological products.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years old or older at time of initial visit\n* Have Type I or Type II diabetes\n* Have a neuropathic diabetic foot ulcer with the following characteristics:\n\n * Is greater than 1 cm2 and less than or equal to 12 cm2\n * Has failed to close following at least 2 treatments with a biologic\n * Has been present for 90 days or longer\n * Does not show signs of infection\n * Is full thickness (Wagner Grade I or II)\n * Located distal to the malleolus\n * Depth of less than or equal to 5 mm\n * No exposed capsule, tendon or bone\n * No tunneling, undermining or sinus tracts\n * Not between the toes\n* Be willing and able to maintain required off-loading of affected limb\n* Be willing and able to perform necessary dressing changes\n* Have at least one of the following:\n\n * An Ankle-brachial index (ABI) ≥ 0.8\n * TcPO2 of ≥ 30 mmHg\n * A toe pressure of ≥ 50 mmHg\n\nExclusion Criteria:\n\n* Be pregnant or be planning to become pregnant during the study\n* Have had a Chopart's Amputation (or higher)\n* Have a history of bone cancer of the affected limb\n* Be undergoing dialysis\n* Have active osteomyelitis or be receiving treatment for osteomyelitis\n* Be diagnosed with unstable Charcot Foot on the affected side\n* Have an HbA1c level of ≥ 12% within the past 90 days\n* Have another ulcer within 2 cm of the study ulcer\n* Be immunocompromised or at risk of immunosuppression as determined by the treating investigator\n* Have a known collagen vascular disease or connective tissue disease\n* Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks\n* Be participating in another medical research study\n* Have a sensitivity to porcine material"}, 'identificationModule': {'nctId': 'NCT03232333', 'acronym': 'H2H-DFU', 'briefTitle': 'MIRODERM H2H DFU Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miromatrix Medical Inc.'}, 'officialTitle': 'Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': '2016002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MIRODERM', 'description': 'Biologic wound graft', 'interventionNames': ['Device: Biologic wound graft']}], 'interventions': [{'name': 'Biologic wound graft', 'type': 'DEVICE', 'otherNames': ['MIRODERM Biologic Wound Matrix treatment'], 'description': 'Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix', 'armGroupLabels': ['MIRODERM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92009', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'ILD Research', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Bond Clinic / Clinical Reseach of Central Florida', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'American Health Network', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '66125', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Institute of Podiatry', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Anthony's Wound Care Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10550', 'city': 'Mount Vernon', 'state': 'New York', 'country': 'United States', 'facility': 'A Step Ahead Foot Care', 'geoPoint': {'lat': 40.9126, 'lon': -73.83708}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Gramercy Park Podiatry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Foot Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '84770', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Foot and Ankle Institute', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}], 'overallOfficials': [{'name': 'Robert Fridman, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foot Associates of New York'}, {'name': 'M Mason Macenski, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Miromatrix'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miromatrix Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}