Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-22 @ 8:09 AM
Study NCT ID:
NCT01816906
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2013-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Testing of a New Generation of Diabetic Footwear
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'n.chockalingam@staffs.ac.uk', 'phone': '+44 1782 295853', 'title': 'Professor Nachiappan Chockalingam', 'organization': 'Staffordshire University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Technical problems with in-shoe plantar pressure measurements lead to unreliable data.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postural Sway During Shod Standing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'OG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds.\n\nArea of the center of pressure excursion', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ankle Strength Left 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'OG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'spread': '40', 'groupId': 'OG000'}, {'value': '116', 'spread': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Strength during dorsi flexion using Citec Dynamometer', 'unitOfMeasure': 'N', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ankle Strength Left 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'OG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'spread': '47', 'groupId': 'OG000'}, {'value': '140', 'spread': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Strength during plantar flexion using Citec Dynamometer', 'unitOfMeasure': 'N', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ankle Strength Right 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'OG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'spread': '37', 'groupId': 'OG000'}, {'value': '110', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Strength during dorsi flexion using Citec Dynamometer', 'unitOfMeasure': 'N', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ankle Strength Right 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'OG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'spread': '45', 'groupId': 'OG000'}, {'value': '141', 'spread': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Strength during plantar flexion using Citec Dynamometer', 'unitOfMeasure': 'N', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vibration Perception Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'OG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '19', 'groupId': 'OG000'}, {'value': '65', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months', 'description': 'Average of left and right (8 measurement areas per foot)', 'unitOfMeasure': 'V', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'FG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles.'}], 'periods': [{'title': 'Six Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Did Not Show Up for Baseline Measurement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}, {'title': '12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.\n\nFootwear: MCP: One group of patients will receive footwear with MCP insoles'}, {'id': 'BG001', 'title': 'PU Insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.\n\nFootwear :PU: One group of patients will receive "Footwear" with PU insoles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '1.67', 'spread': '0.08', 'groupId': 'BG001'}, {'value': '1.65', 'spread': '0.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '11', 'groupId': 'BG000'}, {'value': '77', 'spread': '13', 'groupId': 'BG001'}, {'value': '75', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '12.2', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '12.8', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2013-03-14', 'resultsFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-11', 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vibration Perception Threshold', 'timeFrame': 'Up to 6 months', 'description': 'Average of left and right (8 measurement areas per foot)'}], 'primaryOutcomes': [{'measure': 'Postural Sway During Shod Standing', 'timeFrame': '6 months', 'description': 'Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds.\n\nArea of the center of pressure excursion'}], 'secondaryOutcomes': [{'measure': 'Ankle Strength Left 1', 'timeFrame': 'Up to 6 months', 'description': 'Strength during dorsi flexion using Citec Dynamometer'}, {'measure': 'Ankle Strength Left 2', 'timeFrame': 'Up to 6 months', 'description': 'Strength during plantar flexion using Citec Dynamometer'}, {'measure': 'Ankle Strength Right 1', 'timeFrame': 'Up to 6 months', 'description': 'Strength during dorsi flexion using Citec Dynamometer'}, {'measure': 'Ankle Strength Right 2', 'timeFrame': 'Up to 6 months', 'description': 'Strength during plantar flexion using Citec Dynamometer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Complications', 'Diabetic Neuropathies']}, 'referencesModule': {'references': [{'pmid': '25012640', 'type': 'BACKGROUND', 'citation': 'Chatzistergos PE, Naemi R, Chockalingam N. An MRI compatible loading device for the reconstruction of clinically relevant plantar pressure distributions and loading scenarios of the forefoot. Med Eng Phys. 2014 Sep;36(9):1205-11. doi: 10.1016/j.medengphy.2014.06.006. Epub 2014 Jul 7.'}, {'pmid': '26044551', 'type': 'BACKGROUND', 'citation': 'Naemi R, Chatzistergos PE, Chockalingam N. A mathematical method for quantifying in vivo mechanical behaviour of heel pad under dynamic load. Med Biol Eng Comput. 2016 Mar;54(2-3):341-50. doi: 10.1007/s11517-015-1316-5. Epub 2015 Jun 5.'}, {'pmid': '25245020', 'type': 'BACKGROUND', 'citation': 'Healy A, Naemi R, Chockalingam N. The effectiveness of footwear and other removable off-loading devices in the treatment of diabetic foot ulcers: a systematic review. Curr Diabetes Rev. 2014;10(4):215-30. doi: 10.2174/1573399810666140918121438.'}, {'pmid': '23643441', 'type': 'BACKGROUND', 'citation': 'Healy A, Naemi R, Chockalingam N. The effectiveness of footwear as an intervention to prevent or to reduce biomechanical risk factors associated with diabetic foot ulceration: a systematic review. J Diabetes Complications. 2013 Jul-Aug;27(4):391-400. doi: 10.1016/j.jdiacomp.2013.03.001. Epub 2013 May 1.'}, {'type': 'BACKGROUND', 'citation': 'NAEMI, R., HEALY, A., Sundar, L., Ramachandran, A.R. and CHOCKALINGAM, N., 2013. A Combined Technique for Randomisation of a Small Number of Participants with a Variety of Covariates into Treatment and Control Groups in Randomised Controlled Trials. Journal of Clinical Trials, 4(01).'}, {'pmid': '28484892', 'type': 'RESULT', 'citation': 'Chatzistergos PE, Naemi R, Healy A, Gerth P, Chockalingam N. Subject Specific Optimisation of the Stiffness of Footwear Material for Maximum Plantar Pressure Reduction. Ann Biomed Eng. 2017 Aug;45(8):1929-1940. doi: 10.1007/s10439-017-1826-4. Epub 2017 May 9.'}, {'pmid': '30114460', 'type': 'RESULT', 'citation': 'Healy A, Naemi R, Sundar L, Chatzistergos P, Ramachandran A, Chockalingam N. Hallux plantar flexor strength in people with diabetic neuropathy: Validation of a simple clinical test. Diabetes Res Clin Pract. 2018 Oct;144:1-9. doi: 10.1016/j.diabres.2018.07.038. Epub 2018 Aug 13.'}, {'pmid': '28259007', 'type': 'RESULT', 'citation': 'Naemi R, Chatzistergos P, Suresh S, Sundar L, Chockalingam N, Ramachandran A. Can plantar soft tissue mechanics enhance prognosis of diabetic foot ulcer? Diabetes Res Clin Pract. 2017 Apr;126:182-191. doi: 10.1016/j.diabres.2017.02.002. Epub 2017 Feb 10.'}, {'pmid': '27338509', 'type': 'RESULT', 'citation': 'Naemi R, Chatzistergos P, Sundar L, Chockalingam N, Ramachandran A. Differences in the mechanical characteristics of plantar soft tissue between ulcerated and non-ulcerated foot. J Diabetes Complications. 2016 Sep-Oct;30(7):1293-9. doi: 10.1016/j.jdiacomp.2016.06.003. Epub 2016 Jun 8.'}, {'pmid': '25937545', 'type': 'RESULT', 'citation': 'Chatzistergos PE, Naemi R, Chockalingam N. A method for subject-specific modelling and optimisation of the cushioning properties of insole materials used in diabetic footwear. Med Eng Phys. 2015 Jun;37(6):531-8. doi: 10.1016/j.medengphy.2015.03.009. Epub 2015 Apr 27.'}, {'pmid': '24795257', 'type': 'RESULT', 'citation': 'Chatzistergos PE, Naemi R, Sundar L, Ramachandran A, Chockalingam N. The relationship between the mechanical properties of heel-pad and common clinical measures associated with foot ulcers in patients with diabetes. J Diabetes Complications. 2014 Jul-Aug;28(4):488-93. doi: 10.1016/j.jdiacomp.2014.03.011. Epub 2014 Mar 22.'}, {'pmid': '25454742', 'type': 'RESULT', 'citation': 'Blazkiewicz M, Sundar L, Healy A, Ramachandran A, Chockalingam N, Naemi R. Assessment of lower leg muscle force distribution during isometric ankle dorsi and plantar flexion in patients with diabetes: a preliminary study. J Diabetes Complications. 2015 Mar;29(2):282-7. doi: 10.1016/j.jdiacomp.2014.10.007. Epub 2014 Oct 22.'}, {'type': 'RESULT', 'citation': 'Naemi, R., Linyard-Tough, K., Healy, A. and Chockalingam, N., 2015. The influence of slow recovery insole on plantar pressure and contact area during walking. Journal of Mechanics in Medicine and Biology, 15(02), p.1540005.'}], 'seeAlsoLinks': [{'url': 'http://www.diabsmart.eu', 'label': 'DiaBSmart'}]}, 'descriptionModule': {'briefSummary': 'This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.', 'detailedDescription': 'DiaBSmart as a project aims to generate, transfer and exchange the clinical, academic and production knowledge between the partners to create a new generation of diabetic footwear through a newly developed patient assessment system. The transfer of knowledge between various sectors ensures that the need of patients is considered and transferred effectively to product development using a scientific approach. The objectives include:(1) the design and development of an integrated system of DIABetic foot assessment (2) to validate the newly developed system using experimental methods (3) to develop a suitable material to meet the mechanical and clinical requirements (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications. The Numerical, Experimental and Mathematical Analyses system will integrate all aspects of diabetic footwear including; clinical and biomechanical assessment, material choice and aesthetic design. Proposed interdisciplinary, inter-sectorial approach is unique and brings together the expertise from research institutions, industry and clinics. This project while enhancing the knowledge base in diabetic assessment; will have a clear impact on new product development leading to both clinical and economic benefits. The products include a new generation of integrated SMART /multi material midsoles and/or orthoses for diabetic footwear. Properties of the materials will be optimised with a view to minimise/ redistribute the pressure and hence the stress on the soft tissue in the critical plantar areas of the foot. Whilst significantly affecting the course of the disease, the products will aim to reduce the risk of limb loss in patients with diabetes, the most frequent cause of non-traumatic lower-limb amputations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Diabetes by WHO criteria\n* Lack of sensation to 10 g monofilament or VPT \\>25 V\n* Ability to walk independently for 10 m\n* No ambulatory status\n* No severe foot deformity like Charcot foot\n* Willingness to be assigned to randomisation of footwear\n* At least one palpable pedal pulse on each foot\n\nExclusion Criteria:\n\n* Previous ulceration or current Trophic Ulcers\n* Active foot infection\n* Alzheimer and dementia and impaired cognitive function\n* Gross abnormality or Foot deformity requiring footbed customisation\n* Chronic Kidney Disease\n* Hammer toes\n* Previous foot surgeries'}, 'identificationModule': {'nctId': 'NCT01816906', 'acronym': 'DiaBSmart', 'briefTitle': 'Development and Testing of a New Generation of Diabetic Footwear', 'organization': {'class': 'OTHER', 'fullName': 'Staffordshire University'}, 'officialTitle': 'Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials', 'orgStudyIdInfo': {'id': 'DiaBSmart-01'}, 'secondaryIdInfos': [{'id': 'DiaBSmart -2011-IAPP', 'type': 'OTHER_GRANT', 'domain': 'FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MCP Insole', 'description': 'The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.', 'interventionNames': ['Device: Footwear: MCP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PU insole', 'description': 'The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.', 'interventionNames': ['Device: Footwear :PU']}], 'interventions': [{'name': 'Footwear :PU', 'type': 'DEVICE', 'description': 'One group of patients will receive "Footwear" with PU insoles', 'armGroupLabels': ['PU insole']}, {'name': 'Footwear: MCP', 'type': 'DEVICE', 'description': 'One group of patients will receive footwear with MCP insoles', 'armGroupLabels': ['MCP Insole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600008', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'IDRF/ AR Hopsitals', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}], 'overallOfficials': [{'name': 'Nachiappan Chockalingam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staffordshire University'}, {'name': 'Lakshmi Sundar, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AR Hospitals/ IDRF'}, {'name': 'Roozbeh Naemi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Staffordshire University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Staffordshire University', 'class': 'OTHER'}, 'collaborators': [{'name': "India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Biomechanics Facility', 'investigatorFullName': 'Nachiappan Chockalingam', 'investigatorAffiliation': 'Staffordshire University'}}}}