Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-01 @ 10:09 AM
Study NCT ID:
NCT02211495
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2014-08-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'k.williams@imperial.ac.uk', 'title': 'Miss Kate Williams', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'No Device', 'description': 'Medical therapy, no device.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Device', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Day Until 50% Healing of Leg Ulcer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device', 'description': 'Medical therapy only.'}, {'id': 'OG001', 'title': 'Device', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '5', 'groupId': 'OG000'}, {'value': '30', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Time to 50% healing of leg ulcer, as measured by volume (3D camera)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life (PAID, EQ5D, VAS, SF-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device (Week 0)', 'description': 'Medical therapy, no device.'}, {'id': 'OG001', 'title': 'No Device (Week 6)', 'description': 'Medical therapy, no device, week 6.'}, {'id': 'OG002', 'title': 'Device (Week 0)', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg.\n\nWeek 0'}, {'id': 'OG003', 'title': 'Device (Week 6)', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week, week 6.'}], 'classes': [{'title': 'PAID', 'categories': [{'measurements': [{'value': '22.8', 'spread': '14', 'groupId': 'OG000'}, {'value': '13', 'spread': '1', 'groupId': 'OG001'}, {'value': '21.2', 'spread': '7', 'groupId': 'OG002'}, {'value': '17.3', 'spread': '14', 'groupId': 'OG003'}]}]}, {'title': 'EQ5D', 'categories': [{'measurements': [{'value': '.54', 'spread': '.4', 'groupId': 'OG000'}, {'value': '.7', 'spread': '.2', 'groupId': 'OG001'}, {'value': '.18', 'spread': '.4', 'groupId': 'OG002'}, {'value': '.4', 'spread': '.4', 'groupId': 'OG003'}]}]}, {'title': 'VAS', 'categories': [{'measurements': [{'value': '58', 'spread': '13', 'groupId': 'OG000'}, {'value': '60', 'spread': '14', 'groupId': 'OG001'}, {'value': '37', 'spread': '38', 'groupId': 'OG002'}, {'value': '55', 'spread': '23', 'groupId': 'OG003'}]}]}, {'title': 'SF-12', 'categories': [{'measurements': [{'value': '82.1', 'spread': '12', 'groupId': 'OG000'}, {'value': '67', 'spread': '9', 'groupId': 'OG001'}, {'value': '66', 'spread': '14', 'groupId': 'OG002'}, {'value': '72', 'spread': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID ("Problem Areas in Diabetes") - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS ("visual analogue scale") - For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100) SF 12 ("short form 12") - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Device', 'description': 'Treated with best medical therapy\n\nBest Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice'}, {'id': 'FG001', 'title': 'Device', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.\n\nGEKO device: Placed on the lateral aspect of the knee, when activated it causes the leg to twitch\n\nBest Medical Therapy: Seen in outpatient clinic for wound care and ongoing advice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Device', 'description': 'Medical therapy'}, {'id': 'BG001', 'title': 'Device', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '76'}, {'value': '69.5', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '87'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2014-08-05', 'resultsFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2014-08-06', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-02', 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Day Until 50% Healing of Leg Ulcer', 'timeFrame': '8 weeks', 'description': 'Time to 50% healing of leg ulcer, as measured by volume (3D camera)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (PAID, EQ5D, VAS, SF-12)', 'timeFrame': '6 weeks', 'description': 'Improvement in quality of life questionnaire values, comparing baseline to 6 weeks with treatment PAID ("Problem Areas in Diabetes") - score 0-80, 0 is no problem, 80 is serious problem EQ5D (standardised instrument for generic quality of life score, https://en.wikipedia.org/wiki/EQ-5D) - combination of different dimensions of health to form an overall index, 1.0 for a perfect state of health, with 0 on the scale representing the state of being dead VAS ("visual analogue scale") - For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100) SF 12 ("short form 12") - weighted and summed to provide easily interpretable scales for physical and mental health, the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Foot', 'Ulcer healing', 'Medical device to increase blood flow in foot'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes', 'detailedDescription': "Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that diabetes will be the 7th leading cause of death. Diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes, often co-existing with neuropathy and peripheral vascular disease which compromise the limb's ability to heal. Foot infections in this cohort are common, and diabetic foot ulcers serve as a portal for infective organisms to enter the body. Unchecked, infection can spread contiguously to involve underlying tissues, including bone. A diabetic foot infection is often the pivotal event leading to gangrene and lower extremity amputation. Diabetes accounts for over one million leg amputations every year, and represents 60% of all amputations in developed countries.\n\nDue to the potential for rapid progression of infection, and the gravity of potential complications, diabetic foot problems are handled aggressively in the community, with a low threshold for referral to secondary care. Out-patient clinics involve a multidisciplinary team of clinicians, podiatrists and vascular surgeons. Good foot care is taught to all diabetic patients, and treatment with antibiotics, debridement and revascularisation should occur as a matter of urgency where appropriate.\n\nThe device to be tested mimics the effect of walking by making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. It is hypothesised that increasing blood flow to the limb, much as surgical revascularisation, will aid the legs ability to heal and fight infection. After training, it can be used by patients on themselves and is suitable for out-patient therapy.\n\nThe investigators wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic foot ulceration as a therapeutic intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* 18+ years old\n* Type 2 diabetes on best medical therapy\n* Active foot ulceration, present \\<3 months Exclusion criteria\n* Pregnancy\n* Pacemaker\n* Metal implants in the legs (below knee)'}, 'identificationModule': {'nctId': 'NCT02211495', 'briefTitle': 'ULCERS - Electrical Stimulation in Diabetic Foot Ulceration', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Electrical Stimulation in Diabetic Foot Ulceration', 'orgStudyIdInfo': {'id': '14/SC/0084'}, 'secondaryIdInfos': [{'id': '14HH1901', 'type': 'OTHER', 'domain': 'Imperial College JRCO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No device', 'description': 'Treated with best medical therapy', 'interventionNames': ['Other: Best Medical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Device', 'description': 'As well as receiving best medical therapy, these people will be given the geko device to wear on their affected leg. They will wear it for 4 hours per day, 5 days a week.', 'interventionNames': ['Device: GEKO device', 'Other: Best Medical Therapy']}], 'interventions': [{'name': 'GEKO device', 'type': 'DEVICE', 'description': 'Placed on the lateral aspect of the knee, when activated it causes the leg to twitch', 'armGroupLabels': ['Device']}, {'name': 'Best Medical Therapy', 'type': 'OTHER', 'description': 'Seen in outpatient clinic for wound care and ongoing advice', 'armGroupLabels': ['Device', 'No device']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Diabetic Foot Clinic, Praed Street, Paddington', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Kate Williams', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}