Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
Study NCT ID:
NCT03903692
Status:
TERMINATED
Last Update Posted:
2024-06-25
First Post:
2019-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamiller@medline.com', 'phone': '630-418-6891', 'title': 'Julie Miller', 'organization': 'Medline Industries, LP'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 16, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Adverse Event', 'notes': 'skin conditions found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Events were found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Ablation. not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Found to be related to CoFlex product, not the investigational product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Ulcers, found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Suspected infections were found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Pulmonary congestion with pleural effusion. Found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Event', 'notes': 'Venaseal and end of organ failure. Found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Serious Adverse Event', 'notes': 'Patient fell due to pre-existing condition of neuropathy condition not related to her wound. Found not to be related to the products in the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious Adverse Event', 'notes': 'This SAE was not related to the study products and relevant medical history to this SAE was diabetes, heart burn, deep vein thrombosis (DVT), irregular heartbeat, and hypertension. subject completed final visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'All-Cause Mortality', 'notes': 'Death - The unexpected adverse event was end organ failure and not related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious Adverse Event', 'notes': 'Subject was admitted to the hospital due to rectal bleeding. Found not to be related to study products.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Wound Size From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.'}, {'id': 'OG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.61', 'spread': '36.76', 'groupId': 'OG000'}, {'value': '56.41', 'spread': '61.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 56 days', 'description': 'Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison', 'unitOfMeasure': '% change in wound area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluation of Peri-ulcer Skin Assessment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.'}, {'id': 'OG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'spread': '18.15', 'groupId': 'OG000'}, {'value': '24.39', 'spread': '18.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 56 days', 'description': 'peri-ulcer skin assessment scale is used for assessment. There are 9 systemically items edema, erythema, white atrophy, venous pigmentation, papulovesicular erythema, hyperkeratosis, purpuric patches, telengiectasis, \\& itching lesions. Each is measured for an extension score 0-4 (0=none; 1=punctual, no extension; 2=local, no extension, does not include total ulcer perimeter; 3=includes total ulcer perimeter, does not include spread beyond; 4=spreads beyond total ulcer perimeter) \\& severity score from 0-3 (=-none; 1=only detected following examination; 2=clearly apparent; 3=as evident as the wound). The global score is the extension score multiplied by the severity score. Global scores are added together to a total score. Total score scale range 0 - 70 with 0 being the best score and 70 being the worst. All sub-score values, 0 is best score; higher values indicate worsening wounds.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on a Pain Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.'}, {'id': 'OG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '2.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 56 days', 'description': 'Pain was assessed at each dressing change over the course of the study on a scale of 0-10 with 0 being no pain and 10 being the worst pain. The pain score reported was the average of all scores taken at each dressing change for all patients from baseline to 56 days.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants at all dressing changes.'}, {'type': 'SECONDARY', 'title': 'Change in Surface Area of the Dressing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.'}, {'id': 'OG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '42.11', 'groupId': 'OG000'}, {'value': '12.65', 'spread': '48.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 56 days', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Percent change was calculated as the area of the dressing at time of application minus the area of the dressing at time of removal, divided by the area of the dressing at time of application, times 100.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.'}, {'id': 'FG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '13 subjects were withdrawn from the study and 6 subjects had unusable data. The analysis was performed on the remaining 43 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Marine Polysaccharide Dressing', 'description': 'Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.'}, {'id': 'BG001', 'title': 'Carboxymethylcellulose Dressing', 'description': 'Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.30', 'spread': '13.14', 'groupId': 'BG000'}, {'value': '66.75', 'spread': '11.20', 'groupId': 'BG001'}, {'value': '65.98', 'spread': '12.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-30', 'size': 3929957, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-19T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'Internal stakeholders withdrew funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2019-04-02', 'resultsFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-29', 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Wound Size From Baseline', 'timeFrame': 'Baseline to 56 days', 'description': 'Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Peri-ulcer Skin Assessment Scale', 'timeFrame': 'Baseline to 56 days', 'description': 'peri-ulcer skin assessment scale is used for assessment. There are 9 systemically items edema, erythema, white atrophy, venous pigmentation, papulovesicular erythema, hyperkeratosis, purpuric patches, telengiectasis, \\& itching lesions. Each is measured for an extension score 0-4 (0=none; 1=punctual, no extension; 2=local, no extension, does not include total ulcer perimeter; 3=includes total ulcer perimeter, does not include spread beyond; 4=spreads beyond total ulcer perimeter) \\& severity score from 0-3 (=-none; 1=only detected following examination; 2=clearly apparent; 3=as evident as the wound). The global score is the extension score multiplied by the severity score. Global scores are added together to a total score. Total score scale range 0 - 70 with 0 being the best score and 70 being the worst. All sub-score values, 0 is best score; higher values indicate worsening wounds.'}, {'measure': 'Score on a Pain Scale.', 'timeFrame': 'Baseline to 56 days', 'description': 'Pain was assessed at each dressing change over the course of the study on a scale of 0-10 with 0 being no pain and 10 being the worst pain. The pain score reported was the average of all scores taken at each dressing change for all patients from baseline to 56 days.'}, {'measure': 'Change in Surface Area of the Dressing', 'timeFrame': 'Baseline to 56 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able and willing to comply with requirements of this trial protocol\n* Voluntarily signed informed consent before any trial related procedures are performed\n* Subjects must be able to communicate effectively with study personnel\n* Subject has lower extremity venous ulcer wound, as determined by site PI.\n* Subject has adequate circulation as determined by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.\n* Subjects should not be allergic to silver (Ag).\n* Size of subject's wound is between 1 squared centimeter and 100 squared centimeters.\n* Duration of subject's wound is less than 52 weeks.\n\nExclusion Criteria:\n\n* Subjects who are pregnant, nursing, or planning to become pregnant during the course of the study.\n* Subjects who have known allergies to any ingredient(s) in the clinical products used in this study.\n* Subjects who do not wish to use products derived from shellfish.\n* Subjects with substance use disorder.\n* Subjects with active infection or currently receiving antibiotic treatment.\n* Subjects who are currently enrolled in another research study which includes investigational treatment and/or medication.\n* Subjects judged by the investigator or sub-investigator to be inappropriate as a subject of this study.\n* Subject has previous or current systemic disease(s) which, in the judgement of the site PI, is likely to interfere with the study. However, subjects with well-controlled diabetes mellitus (HbA1C \\< 8.5) shall be permitted."}, 'identificationModule': {'nctId': 'NCT03903692', 'briefTitle': 'A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medline Industries'}, 'officialTitle': 'A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) Dressing on Subjects With Lower Extremity Venous Ulcers', 'orgStudyIdInfo': {'id': 'MED-2018-DIV71-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Marine polysaccharide dressing', 'interventionNames': ['Device: Marine polysaccharide dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carboxymethylcellulose dressing', 'interventionNames': ['Device: Carboxymethylcellulose dressing']}], 'interventions': [{'name': 'Marine polysaccharide dressing', 'type': 'DEVICE', 'description': 'The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.', 'armGroupLabels': ['Marine polysaccharide dressing']}, {'name': 'Carboxymethylcellulose dressing', 'type': 'DEVICE', 'description': 'The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.', 'armGroupLabels': ['Carboxymethylcellulose dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Vascular Surgery Associates', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '93662', 'city': 'Selma', 'state': 'California', 'country': 'United States', 'facility': 'Central Valley Vein and Wound Center', 'geoPoint': {'lat': 36.57078, 'lon': -119.61208}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Covenant Hospital', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medline Industries', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}