Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-06 @ 11:10 AM
Study NCT ID:
NCT01239160
Status:
TERMINATED
Last Update Posted:
2020-11-06
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astone@tactilemedical.com', 'phone': '612-540-5267', 'title': 'Director of Clinical Research', 'organization': 'Tactile Medical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination DSMB recommendation on 23Jan2012 due to underpowered endpoint in 26Oct2011 dataset. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events reported below were collected from Baseline through 24 week visit.', 'description': 'Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.', 'eventGroups': [{'id': 'EG000', 'title': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume\n\nFlexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 25, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume\n\nHydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 15, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Worsened swelling/Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting/Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis/Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Edema', 'notes': 'Study leg became markedly swollen (no cellulitis).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Extreme shooting pain followed by swelling and hardness of the leg.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'notes': 'New diagnosis of lung cancer.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured legs', 'notes': 'Fractured legs from motor vehicle accident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discoloration of toes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breathlessness', 'notes': 'Breathlessness and dizziness.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume\n\nFlexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day'}, {'id': 'OG001', 'title': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume\n\nHydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.'}], 'classes': [{'title': 'Change Baseline to 1-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.1', 'spread': '652.3', 'groupId': 'OG000'}, {'value': '75.3', 'spread': '678.0', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 4-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '636.3', 'groupId': 'OG000'}, {'value': '99.7', 'spread': '691.3', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 8-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.7', 'spread': '756.6', 'groupId': 'OG000'}, {'value': '167.9', 'spread': '760.7', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 12-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.1', 'spread': '724.5', 'groupId': 'OG000'}, {'value': '216.1', 'spread': '919.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.', 'description': 'Limb volume in ml as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset. Data analyzed for subjects with measures assessed at the noted timepoint. Subjects who missed a visit or who did not complete the assessment at the visit were excluded.'}, {'type': 'PRIMARY', 'title': 'Limb Volume Change Baseline to 12 Weeks of Treatment - Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume\n\nFlexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day'}, {'id': 'OG001', 'title': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume\n\nHydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.'}], 'classes': [{'title': 'Change Baseline to 1-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 4-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 8-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Change Baseline to 12-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.', 'description': 'Limb volume (percent change from baseline) as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset. Data analyzed for subjects with measures assessed at the noted timepoint. Subjects who missed visits or who did not complete the assessment at the visit were excluded.'}, {'type': 'SECONDARY', 'title': 'Adverse Events - Totals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume\n\nFlexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day'}, {'id': 'OG001', 'title': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume\n\nHydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.'}], 'classes': [{'title': 'Total Serious Adverse Events (SAE)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Device-Related SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Procedure-Related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Unrelated SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total Non-Serious Adverse Events (NSAE)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Device-Related NSAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Procedure-Related NSAE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Unrelated NSAE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 238 patients "started" in Participant Flow, 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume\n\nFlexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day'}, {'id': 'FG001', 'title': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume\n\nHydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.'}, {'id': 'FG002', 'title': 'Treatment Not Assigned', 'description': 'Consented, but did withdrawn prior to being randomized into one of the treatment groups.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Of the 238 patients "started", 64 APCD and 66 SPCD had reached the 12 week visit milestone at the time of the outcome analysis reported below. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Early Termination Due to Study Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume\n\nFlexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day.'}, {'id': 'BG001', 'title': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume\n\nHydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', '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': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Etiology of Lymphedema', 'classes': [{'categories': [{'title': 'Primary', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Secondary', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Severity of Lymphedema', 'classes': [{'categories': [{'title': 'Late Stage II', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Stage III', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Late stage 2 is defined as prolonged swelling spontaneously irreversible, pitting becomes difficult to produce, presence of fibrosis, history of infection, the difference in circumference is between 4 and 6 cm (at a single point of measurement).\n\nStage 3, considered worse than stage 2, is defined as presence of skin folds, severe tissue induration (fibrosis and sclerosis), skin changes (papillomas, hyperkeratosis, lymph cysts, fistulas), the difference in circumference is between greater than 6 cm (at a single point of measurement).', 'unitOfMeasure': 'Participants'}, {'title': 'Hosiery Used', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'whyStopped': 'Futility and underpowering of endpoint data', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2012-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2010-11-10', 'resultsFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-18', 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limb Volume Change Between Baseline and 12 Weeks of Treatment - ml', 'timeFrame': 'Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.', 'description': 'Limb volume in ml as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.'}, {'measure': 'Limb Volume Change Baseline to 12 Weeks of Treatment - Percent', 'timeFrame': 'Baseline to 12 weeks was the primary outcome; other time points included for informational purposes.', 'description': 'Limb volume (percent change from baseline) as assessed using the tape measure method of collecting circumferential leg measurements to insert into the truncated cone formula for limb volume calculation. A positive score indicates volume reduction between baseline and the noted follow-up, while a negative score indicates volume increase.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events - Totals', 'timeFrame': 'Up to 24 weeks of treatment', 'description': 'Adverse and serious adverse events will be recorded for patients for the duration of their participation in the trial'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lymphedema', 'pneumatic compression device', 'randomised clinical trial', 'volume reduction'], 'conditions': ['Lymphedema']}, 'descriptionModule': {'briefSummary': 'The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition.\n\nThe treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression.\n\nThis trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.', 'detailedDescription': 'This is a Multicentre, prospective, single (assessor) blind randomised study. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs with an advanced PCD compared to a simple PCD in patients with lower limb lymphoedema. The main outcome is the percentage volume reduction of the affected limb at end of treatment compared to baseline.\n\nSecondary objectives of the study are Assessment of safety Quality of life Health economic parameters\n\nIn total 262 patients with leg lymphoedema will be enrolled into the study. Patients eligible for the study are those who suffer from late stage II and stage III according to the International Society of Lymphology lymphoedema staging. Lymphoedematous legs can be of primary or secondary origin and uni or bilaterally affected. Medical history will be taken at baseline.\n\nPatients will be taught how to use the device they have been randomised to. Visits will then take place at weeks 1,4,8,12 and 24 weeks. The device will be used for up to 60 minutes each day on the trial limb. At each visit sequential circumferences of the affected and unaffected limbs will be measured with a tape measure.\n\nAll adverse events will be documented. At beginning and end of study quality of life questionnaires and health economic information will be completed by the patients.\n\nAt the Derby site assessment of tissue quality will be made using ultrasound and moisture meter to assess tissue fluid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be ≥ 18 years old or legal age in host country.\n* Subjects must have a diagnosis of primary or secondary late Stage 2 or 3 unilateral or bilateral lower extremity lymphoedema.\n* At time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable.\n* If subjects were treated in a clinic setting for lymphoedema (Phase 1 treatment) they must be at least 3 months post completion of their acute care.\n\nExclusion Criteria:\n\n* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer.\n* Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study.\n* Diagnosis of acute thrombophlebitis (in last 2 months)\n* Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower.\n* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months\n* Diagnosis of pulmonary edema\n* Diagnosis of congestive heart failure (uncontrolled)\n* Diagnosis of chronic kidney disease with a Glomerular Filtration Rate (GFR) of less than 30 mls per minute.\n* Patients with poorly controlled asthma (i.e. those with severe persistent symptoms throughout the day, night time awakenings several times per week, use of a beta2 agonist inhaler several times per day and those whose normal activity is extremely limited).\n* Pregnancy\n* Any condition where increased venous and lymphatic return is undesirable\n* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent\n* Currently participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT01239160', 'acronym': 'ACE', 'briefTitle': 'Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tactile Medical'}, 'officialTitle': 'At Home Evaluation of Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphoedema(ACE: At Home Compression Evaluation)', 'orgStudyIdInfo': {'id': 'Flexitouch 1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced PCD', 'description': 'The use of an advanced PCD device to reduce and maintain limb volume', 'interventionNames': ['Device: Flexitouch System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simple PCD', 'description': 'The use of the Simple PCD is to reduce and maintain limb volume', 'interventionNames': ['Device: Hydroven FPR']}], 'interventions': [{'name': 'Flexitouch System', 'type': 'DEVICE', 'description': 'A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day', 'armGroupLabels': ['Advanced PCD']}, {'name': 'Hydroven FPR', 'type': 'DEVICE', 'description': 'The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.', 'armGroupLabels': ['Simple PCD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education & Research Cooperative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia,Ellis Fischel Cancer Center, Lymphedema Therapy Clinic', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '11794-8191', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Rehabilitation', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital Systems', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '05446', 'city': 'Colchester', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care, Inc., University of Vermont', 'geoPoint': {'lat': 44.54394, 'lon': -73.14791}}, {'city': 'Adelaide', 'country': 'Australia', 'facility': 'Flinders Medical Center', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': 'LE3 9QE', 'city': 'Leicester', 'state': 'Leics', 'country': 'United Kingdom', 'facility': 'LOROS Hospice', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Mansfield', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': "King's Mill Hospital", 'geoPoint': {'lat': 53.13333, 'lon': -1.2}}, {'zip': 'G12 8LL', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Swansea', 'state': 'West Glamorgan', 'country': 'United Kingdom', 'facility': 'Abertawe Bro Morgannwg University', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'NE25 8SU', 'city': 'Gosforth', 'country': 'United Kingdom', 'facility': 'St Oswalds Hospice', 'geoPoint': {'lat': 55.0, 'lon': -1.61667}}, {'zip': 'LA9 4BD', 'city': 'Kendal', 'country': 'United Kingdom', 'facility': 'Kendal Lymphology Centre', 'geoPoint': {'lat': 54.32681, 'lon': -2.74757}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Queens Medical Center', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'SA2 8QA', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Lymphoedema Clinic, Singleton Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'WS14 9LH', 'city': 'Whittington', 'country': 'United Kingdom', 'facility': 'St Giles Hospice', 'geoPoint': {'lat': 52.67372, 'lon': -1.76091}}], 'overallOfficials': [{'name': 'Christine J Moffatt, RN PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nottingham Trent University'}, {'name': 'Vaughan Keeley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Derby Hospitals NHS Trust'}, {'name': 'Margaret Sneddon, RGN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}, {'name': 'Peter J Franks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tactile Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tactile Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}