Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-04-23 @ 6:55 PM
Study NCT ID:
NCT02783066
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective 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': 'bijan.najafi@bcm.edu', 'phone': '17137987536', 'title': 'Prof.Bijan Najafi', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will try a new offloading boot for 4 weeks\n\nOffloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lower Extremity Perfusion Change From Baseline to 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will try a new offloading boot for 4 weeks\n\nOffloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'ulcerated', 'categories': [{'measurements': [{'value': '167', 'spread': '71', 'groupId': 'OG000'}]}]}, {'title': 'contralateral', 'categories': [{'measurements': [{'value': '75', 'spread': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Skin perfusion measured in the ankle using Sensilase device. To measure Skin Perfusion Pressure (SPP), a pressure cuff is first automatically inflated to occlude arterial bed blood flow; this is verified by PAD-IQ by determining when perfusion has stopped. The pressure is then automatically released at a controlled rate while the cuff pressure and skin perfusion are measured. A graph displays pressure and perfusion during cuff deflation and indicates the pressure at which skin perfusion is found to return.', 'unitOfMeasure': 'percentage of baseline perfusion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gait Speed Difference Between Pulseflow Offflaoding and Standard Offloading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'Walking speed with Pulse flow offloading', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Walking speed with standard offloading', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'the quality of walking while wearing Pulseflow offflaoding compared to standard offloading', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will try a new offloading boot for 4 weeks\n\nOffloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'categories': [{'measurements': [{'value': '6791', 'spread': '4914', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'adherence to wear offloading boot by downloading from the study device to a specific developed software. The measure is the mean number of minutes the offloading boot was worn for over the course of 4 weeks', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wound Size Change From Baseline to 4 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will try a new offloading boot for 4 weeks\n\nOffloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'categories': [{'measurements': [{'value': '-60', 'spread': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baselineand and 4 weeks', 'description': 'measuring the size of the wound (W, L,H)', 'unitOfMeasure': 'percentage of baseline wound area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stride Length Difference Between Pulseflow Offflaoding and Standard Offloading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'standard offlaoding', 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Pulseflow offlaoding', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'the quality of walking while wearing Pulseflow offflaoding compared to standard offloading', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Limp Difference Between Pulseflow Offflaoding and Standard Offloading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'standard offlaoding', 'categories': [{'measurements': [{'value': '4.38', 'spread': '2.96', 'groupId': 'OG000'}]}]}, {'title': 'Pulseflow offlaoding', 'categories': [{'measurements': [{'value': '2.99', 'spread': '2.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Limp: the difference in stance percent between right and left feet', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Swing Angular Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'offloaded side of standard offloading', 'categories': [{'measurements': [{'value': '172.53', 'spread': '56.85', 'groupId': 'OG000'}]}]}, {'title': 'contralateral side of standard offloading', 'categories': [{'measurements': [{'value': '178.49', 'spread': '60.31', 'groupId': 'OG000'}]}]}, {'title': 'offloaded side of pulseflow offloading', 'categories': [{'measurements': [{'value': '191.72', 'spread': '50.52', 'groupId': 'OG000'}]}]}, {'title': 'contralateral side of pulseflow offloading', 'categories': [{'measurements': [{'value': '166.77', 'spread': '81.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Angular Velocity of leg swing during walking for each side', 'unitOfMeasure': 'degree per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ratio of Propulsion Time to Stance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'offloaded side of standard offloading', 'categories': [{'measurements': [{'value': '55', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': 'contralateral side of standard offloading', 'categories': [{'measurements': [{'value': '60', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'offloaded side of pulseflow offloading', 'categories': [{'measurements': [{'value': '67', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': 'contralateral side of pulseflow offloading', 'categories': [{'measurements': [{'value': '62', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Propulsion time and stance time for each stride is caulcated by wearable sensors. The measure is ratio of propulsion time to stance time as percentage value.', 'unitOfMeasure': 'percentage of stance time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center of Mass Sway While Wearing Standard Offloading Boot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'double stance with eyes open', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'double stance with eyes closed', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'tandem stance with eyes open', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'tandem stance with eyes closed', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Center of Mass (COM) sway measured by wearable inertial sensors', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center of Mass Sway While Wearing Pulseflow Offloading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'double stance with eyes open', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'double stance with eyes closed', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.34', 'groupId': 'OG000'}]}]}, {'title': 'tandem stance with eyes open', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'tandem stance with eyes closed', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'center of mass sway measured by a wearable inertial sensor', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Forefoot Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nPulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'classes': [{'title': 'offloaded side of standard offloading', 'categories': [{'measurements': [{'value': '168.7', 'spread': '156.9', 'groupId': 'OG000'}]}]}, {'title': 'contralateral side of standard offloading', 'categories': [{'measurements': [{'value': '276.7', 'spread': '105.7', 'groupId': 'OG000'}]}]}, {'title': 'offloaded side of pulseflow offloading', 'categories': [{'measurements': [{'value': '147.0', 'spread': '114.3', 'groupId': 'OG000'}]}]}, {'title': 'contralateral side of pulseflow offloading', 'categories': [{'measurements': [{'value': '196.9', 'spread': '84.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'unitOfMeasure': 'Pa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will complete gait and balance test with both new offloading boots and standard offloading boots at baseline, and then use new offloading boots for 4 weeks\n\nOffloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'complete 4-week pulseflow offloading wearing test', 'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '"PulseFlow" Group', 'description': 'Eligible subjects will try a new offloading boot for 4 weeks\n\nOffloading boot : PulseFlow: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '15.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'spread': '5.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-05', 'size': 127012, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-15T23:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2016-05-19', 'resultsFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2016-05-23', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-29', 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Extremity Perfusion Change From Baseline to 4 Weeks', 'timeFrame': 'baseline and 4 weeks', 'description': 'Skin perfusion measured in the ankle using Sensilase device. To measure Skin Perfusion Pressure (SPP), a pressure cuff is first automatically inflated to occlude arterial bed blood flow; this is verified by PAD-IQ by determining when perfusion has stopped. The pressure is then automatically released at a controlled rate while the cuff pressure and skin perfusion are measured. A graph displays pressure and perfusion during cuff deflation and indicates the pressure at which skin perfusion is found to return.'}, {'measure': 'Gait Speed Difference Between Pulseflow Offflaoding and Standard Offloading', 'timeFrame': 'baseline', 'description': 'the quality of walking while wearing Pulseflow offflaoding compared to standard offloading'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '4 weeks', 'description': 'adherence to wear offloading boot by downloading from the study device to a specific developed software. The measure is the mean number of minutes the offloading boot was worn for over the course of 4 weeks'}, {'measure': 'Wound Size Change From Baseline to 4 Weeks.', 'timeFrame': 'baselineand and 4 weeks', 'description': 'measuring the size of the wound (W, L,H)'}, {'measure': 'Stride Length Difference Between Pulseflow Offflaoding and Standard Offloading', 'timeFrame': 'baseline', 'description': 'the quality of walking while wearing Pulseflow offflaoding compared to standard offloading'}, {'measure': 'Limp Difference Between Pulseflow Offflaoding and Standard Offloading', 'timeFrame': 'baseline', 'description': 'Limp: the difference in stance percent between right and left feet'}, {'measure': 'Peak Swing Angular Velocity', 'timeFrame': 'baseline', 'description': 'Angular Velocity of leg swing during walking for each side'}, {'measure': 'Ratio of Propulsion Time to Stance Time', 'timeFrame': 'baseline', 'description': 'Propulsion time and stance time for each stride is caulcated by wearable sensors. The measure is ratio of propulsion time to stance time as percentage value.'}, {'measure': 'Center of Mass Sway While Wearing Standard Offloading Boot', 'timeFrame': 'baseline', 'description': 'Center of Mass (COM) sway measured by wearable inertial sensors'}, {'measure': 'Center of Mass Sway While Wearing Pulseflow Offloading', 'timeFrame': 'baseline', 'description': 'center of mass sway measured by a wearable inertial sensor'}, {'measure': 'Peak Forefoot Pressure', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer', 'Offloading']}, 'descriptionModule': {'briefSummary': "Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Prevention by identifying people at higher risk is key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and possibility of gangrene.\n\nA novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The offloading boot design holds the foot and lower leg in a position that reduces shear and friction forces and provides a reduction in plantar pressure.\n\nThe PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This data will be downloaded at each clinic visit. The boot cannot pump blood around the participant's foot unless fitted correctly and the battery is charged up overnight.\n\nThe purpose of this study is to conduct an interventional study study with N=15 diabetic subjects with active foot ulcers to assess whether PulseFlow foot compression device can help improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of gait.\n\nThe key goals of the proposed project are to test whether a specially designed compression device can improve lower extremity perfusion, whilst also simultaneously improving the balance and walking performance. Investigators envision the use of this specially designed offloading device with compression capability will help reduce the incidence of diabetic foot ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device might enhance daily physical activity as well as walking performance. Investigators will conduct a prospective clinical study to validate these hypotheses. Potential changes in walking and spontaneous daily physical activities will be assessed using validated technologies that include walking analyzer system, balance assessment using body worn sensors, and computerized pressure insoles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18- 80 years old\n* type II diabetes with active plantar ulcer,\n\nExclusion Criteria:\n\n* Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance\n* Plantar ulcer on arch of the foot\n* Patients with PAD (Ankle Brachial Index \\< 0.5)\n* Acute foot fracture\n* Heart failure\n* Pregnant women\n* Patients on immunosuppressive drugs\n* Participation in an interventional study in the last 30 days\n* Major amputation\n* Patients unable or unwilling to participate in all procedures and follow-up evaluations.'}, 'identificationModule': {'nctId': 'NCT02783066', 'briefTitle': 'Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'orgStudyIdInfo': {'id': 'H-37713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"PulseFlow" group', 'description': 'Eligible subjects will try a new offloading boot for 4 weeks', 'interventionNames': ['Device: Offloading boot: PulseFlow']}], 'interventions': [{'name': 'Offloading boot: PulseFlow', 'type': 'DEVICE', 'description': 'A new offloading boot, which may enhance balance, gait, and lower extremity blood flow', 'armGroupLabels': ['"PulseFlow" group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Diabetic Boot Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Bijan Najafi, PhD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}