Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
Study NCT ID:
NCT03426566
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Abnormal Plantar Pressure in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edytasutkowska@yahoo.com', 'phone': '0048503077016', 'title': 'Dr Sutkowska Edyta', 'organization': 'Wroclaw Medical University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Lack of the influence of a type and duration of diabetes mellitus.The neuropathy evaluation based on local recommendations.\n\nThe semi-quantitative analysis of the pressure map; the retrospective nature of the study.'}}, 'adverseEventsModule': {'timeFrame': 'Not applicable- observational, retrospective study with medical-records analysis.', 'description': 'Not applicable- observational, retrospective study with medical-records analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Diabetes', 'description': 'Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.\n\nretrospective observational study with no intervention: no intervention', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abnormal Plantar Pressure Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes', 'description': 'Patients with diabetes from Diabetic Foot Centre'}], 'classes': [{'categories': [{'title': 'patients without APD', 'measurements': [{'value': '80', 'groupId': 'OG000'}]}, {'title': 'patients with APD', 'measurements': [{'value': '894', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 visit', 'description': 'static pedobarographic test with semi-quantitative assessment: number of the patients with abnormal plantar pressure location based on a semi-quantitative method, as static barefoot pedobarographic records with colourful print analysis. The intensity of colour was proportional to the pressure received. Warm colours indicated the greatest pressure, while cold colours indicated the least plantar pressure (starting with red, then yellow, green, and blue)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with diabetes mellitus but without active or past foot ulcer or surgical procedure within the feet. Abnormal plantar pressure distribution (APD) - means number of participants with symmetrical abnormal pressure distribution; No APD- without such kind a distribution.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Test for Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes', 'description': 'Patients with diabetes from Diabetes Foot Center (DFC)'}], 'classes': [{'title': 'PSSN', 'categories': [{'title': 'negative', 'measurements': [{'value': '907', 'groupId': 'OG000'}]}, {'title': 'positive', 'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'MN calluses', 'categories': [{'title': 'negative', 'measurements': [{'value': '645', 'groupId': 'OG000'}]}, {'title': 'positive', 'measurements': [{'value': '329', 'groupId': 'OG000'}]}]}, {'title': 'MN feet deformity', 'categories': [{'title': 'negative', 'measurements': [{'value': '798', 'groupId': 'OG000'}]}, {'title': 'positive', 'measurements': [{'value': '176', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 visit', 'description': 'Peripheral neuropathy is assessed with questions and clinical evaluation. A nurse asks the patient about stinging, numbness, tingling, or burning of the foot. Ten-gram monofilament and tuning fork (128 MHz) tests are administered. Monofilament is applied in 10 locations on the sole and one on the dorsal part of the foot for checking the loss of protective sensation. A positive monofilament test is considered to be the lack of sensation of tightness in at least 6 of 11 tested sites. The tuning fork is applied for vibration detection to both ankles, the first metatarsophalangeal joint, and the anterior aspect of the shin bone sites. A positive vibration test is considered to be no detection of vibration in three of four test sites.Two positive test results and typical symptoms of neuropathy are the basis for confirmation of peripheral symmetric sensory neuropathy (PSSN). The condition required for the occurrence of these disorders was symmetry.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with DM, without active or past ulcer or surgery within the feet.The data was collected, grouped and analyzed separately for: PSSN, motor neuropathy (MN): MN-Calluses and MN-Feet deformity. One patient can developed PSSN and calluses and feet deformity (and thus his/her result was incorporated into each arm) or one of these variables.'}, {'type': 'SECONDARY', 'title': 'BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Diabetes', 'description': 'Patients with diabetes from DFC'}], 'classes': [{'categories': [{'title': 'BMI ≥35 kg/m2', 'measurements': [{'value': '153', 'groupId': 'OG000'}]}, {'title': 'BMI<35 kg/m2', 'measurements': [{'value': '821', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 visit', 'description': 'kg/m2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients after BMI were assigned to one of two groups : BMI\\<35 kg/m2 or ≥35 kg/m2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Diabetes', 'description': 'Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.\n\nretrospective observational study with no intervention: no intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1948', 'numSubjects': '974'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1948', 'numSubjects': '974'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'feet', 'recruitmentDetails': 'Recruitment period: between October 2009 and December 2010 Medical records were obtained from the Diabetic Foot Centre (DFC) in Wroclaw, Poland and covered a period of fifteen months of work.', 'preAssignmentDetails': 'Patients without previous ulcerations or foot surgery were evaluated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'BG000'}]}, {'units': 'feet', 'counts': [{'value': '1948', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Diabetes', 'description': 'Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.\n\nretrospective observational study with no intervention: no intervention'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '478', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '496', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age- was calculated based on patients identification (ID) number (in Poland each ID number contains date of birth).', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '11.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '523', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '451', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'categories': [{'measurements': [{'value': '974', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'feet'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 974}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2018-01-23', 'resultsFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-13', 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal Plantar Pressure Distribution', 'timeFrame': '1 visit', 'description': 'static pedobarographic test with semi-quantitative assessment: number of the patients with abnormal plantar pressure location based on a semi-quantitative method, as static barefoot pedobarographic records with colourful print analysis. The intensity of colour was proportional to the pressure received. Warm colours indicated the greatest pressure, while cold colours indicated the least plantar pressure (starting with red, then yellow, green, and blue)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Positive Test for Neuropathy', 'timeFrame': '1 visit', 'description': 'Peripheral neuropathy is assessed with questions and clinical evaluation. A nurse asks the patient about stinging, numbness, tingling, or burning of the foot. Ten-gram monofilament and tuning fork (128 MHz) tests are administered. Monofilament is applied in 10 locations on the sole and one on the dorsal part of the foot for checking the loss of protective sensation. A positive monofilament test is considered to be the lack of sensation of tightness in at least 6 of 11 tested sites. The tuning fork is applied for vibration detection to both ankles, the first metatarsophalangeal joint, and the anterior aspect of the shin bone sites. A positive vibration test is considered to be no detection of vibration in three of four test sites.Two positive test results and typical symptoms of neuropathy are the basis for confirmation of peripheral symmetric sensory neuropathy (PSSN). The condition required for the occurrence of these disorders was symmetry.'}, {'measure': 'BMI', 'timeFrame': '1 visit', 'description': 'kg/m2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot', 'pedobarography', 'diabetic neuropathy', 'plantar pressure'], 'conditions': ['Diabetes Complications']}, 'referencesModule': {'references': [{'pmid': '6839919', 'type': 'BACKGROUND', 'citation': 'Boulton AJ, Hardisty CA, Betts RP, Franks CI, Worth RC, Ward JD, Duckworth T. Dynamic foot pressure and other studies as diagnostic and management aids in diabetic neuropathy. Diabetes Care. 1983 Jan-Feb;6(1):26-33. doi: 10.2337/diacare.6.1.26.'}, {'pmid': '2956023', 'type': 'BACKGROUND', 'citation': 'Boulton AJ, Betts RP, Franks CI, Newrick PG, Ward JD, Duckworth T. Abnormalities of foot pressure in early diabetic neuropathy. Diabet Med. 1987 May-Jun;4(3):225-8. doi: 10.1111/j.1464-5491.1987.tb00867.x.'}, {'pmid': '3968150', 'type': 'BACKGROUND', 'citation': 'Duckworth T, Boulton AJ, Betts RP, Franks CI, Ward JD. Plantar pressure measurements and the prevention of ulceration in the diabetic foot. J Bone Joint Surg Br. 1985 Jan;67(1):79-85. doi: 10.1302/0301-620X.67B1.3968150.'}, {'type': 'BACKGROUND', 'citation': 'Rich J, Veves A. Forefoot and rearfoot plantar pressures in diabetic patients: correlation to foot ulceration. Wounds2000;12:82-87'}, {'pmid': '9773736', 'type': 'BACKGROUND', 'citation': 'Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care. 1998 Oct;21(10):1714-9. doi: 10.2337/diacare.21.10.1714.'}, {'pmid': '22271736', 'type': 'BACKGROUND', 'citation': 'Bakker K, Schaper NC; International Working Group on Diabetic Foot Editorial Board. The development of global consensus guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:116-8. doi: 10.1002/dmrr.2254.'}, {'pmid': '25437079', 'type': 'BACKGROUND', 'citation': 'Choi YR, Lee HS, Kim DE, Lee DH, Kim JM, Ahn JY. The diagnostic value of pedobarography. Orthopedics. 2014 Dec;37(12):e1063-7. doi: 10.3928/01477447-20141124-52.'}, {'pmid': '26409930', 'type': 'BACKGROUND', 'citation': 'Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ; International Working Group on the Diabetic Foot. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:2-6. doi: 10.1002/dmrr.2694.'}, {'pmid': '26211920', 'type': 'BACKGROUND', 'citation': 'Crawford F, Cezard G, Chappell FM, Murray GD, Price JF, Sheikh A, Simpson CR, Stansby GP, Young MJ. A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS). Health Technol Assess. 2015 Jul;19(57):1-210. doi: 10.3310/hta19570.'}, {'type': 'BACKGROUND', 'citation': 'Inlow S. The 60-second Foot Exam for People with Diabetes. Wound Care Can2004;2:10-11'}, {'pmid': '23308404', 'type': 'BACKGROUND', 'citation': 'Carreau L, Niezgoda H, LeBlond S, Trainor A, Orsted H, Woodbury MG. A prospective, descriptive study to assess the reliability and usability of a rapid foot screen for patients with diabetes mellitus in a complex continuing care setting. Ostomy Wound Manage. 2013 Jan;59(1):28-34.'}, {'type': 'BACKGROUND', 'citation': 'Tuna H, Birtane M, Güldiken S et al. The effect of disease duration on foot plantar pressure values in patients with type 2 diabetes mellitus. Turk J Phys Med Rehab2014;60:231-235'}, {'pmid': '21622632', 'type': 'BACKGROUND', 'citation': 'Lazaro-Martinez JL, Aragon-Sanchez FJ, Beneit-Montesinos JV, Gonzalez-Jurado MA, Garcia Morales E, Martinez Hernandez D. Foot biomechanics in patients with diabetes mellitus: doubts regarding the relationship between neuropathy, foot motion, and deformities. J Am Podiatr Med Assoc. 2011 May-Jun;101(3):208-14. doi: 10.7547/1010208.'}, {'pmid': '17123181', 'type': 'BACKGROUND', 'citation': 'Perell KL, Merrill V, Nouvong A. Location of plantar ulcerations in diabetic patients referred to a Department of Veterans Affairs podiatry clinic. J Rehabil Res Dev. 2006 Jul-Aug;43(4):421-6. doi: 10.1682/jrrd.2005.10.0157.'}, {'pmid': '24012295', 'type': 'BACKGROUND', 'citation': 'Ledoux WR, Shofer JB, Cowley MS, Ahroni JH, Cohen V, Boyko EJ. Diabetic foot ulcer incidence in relation to plantar pressure magnitude and measurement location. J Diabetes Complications. 2013 Nov-Dec;27(6):621-6. doi: 10.1016/j.jdiacomp.2013.07.004. Epub 2013 Sep 4.'}, {'pmid': '11753590', 'type': 'BACKGROUND', 'citation': 'Hills AP, Hennig EM, McDonald M, Bar-Or O. Plantar pressure differences between obese and non-obese adults: a biomechanical analysis. Int J Obes Relat Metab Disord. 2001 Nov;25(11):1674-9. doi: 10.1038/sj.ijo.0801785.'}, {'pmid': '33248407', 'type': 'BACKGROUND', 'citation': 'Sutkowska E, Fortuna P, Kaluza B, Sutkowska K, Hodurek P, Fleszar MG. The impact of Sample Handling Time on metformin serum concentration. Biomed Pharmacother. 2021 Jan;133:110971. doi: 10.1016/j.biopha.2020.110971. Epub 2020 Nov 25.'}, {'pmid': '31380446', 'type': 'RESULT', 'citation': 'Sutkowska E, Sutkowski K, Sokolowski M, Franek E, Dragan S Sr. Distribution of the Highest Plantar Pressure Regions in Patients with Diabetes and Its Association with Peripheral Neuropathy, Gender, Age, and BMI: One Centre Study. J Diabetes Res. 2019 Jul 9;2019:7395769. doi: 10.1155/2019/7395769. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of abnormal plantar pressure distribution (APD) and its connection with various factors among patients with diabetes is not known. The purpose of this study was to evaluate the prevalence of the APD and its connection with selected factors among patients with diabetes.', 'detailedDescription': "The abnormal plantar pressure distribution (APD) plays a key role in the formation of plantar calluses which are responsible for diabetic foot ulcer.\n\nThe knowledge of APD is necessary to plan proper prevention in the group of patients with diabetes mellitus (DM).\n\nMedical records from previous patients' visits of non-ulcer patients with diabetes were retrospectively analysed. The relationship between APD, obtained during a pedobarographic test as a semi-quantitative assessment with colourful print analysis, and neuropathy, gender, age and BMI was searched."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Wroclaw (where the Diabetic Foot Centre exists) citizens who came spontaneously to be examined despite the absence of diabetic foot signs or symptoms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects with diabetes mellitus diagnosis\n* citizens\n* no previous foot ulceration and/or foot surgery\n\nExclusion Criteria:\n\n* previous foot ulceration and/or foot surgery'}, 'identificationModule': {'nctId': 'NCT03426566', 'briefTitle': 'Abnormal Plantar Pressure in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Prevention of Foot Injuries - Abnormal Distribution Patterns of Plantar Pressure in Patients With Diabetes and Its Connection to Peripheral Neuropathy, Gender, Age and BMI', 'orgStudyIdInfo': {'id': 'ST 690'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with diabetes', 'description': 'Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned.', 'interventionNames': ['Other: retrospective observational study with no intervention']}], 'interventions': [{'name': 'retrospective observational study with no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['patients with diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54-438', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Department and Division of Medical Rehabilitation', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Edyta Sutkowska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'no limit', 'ipdSharing': 'YES', 'description': 'all collected individual participant data but without individual foot-print picture (mostly paper documentation) ; only the example of foot -print with explanation is available', 'accessCriteria': 'will be included in an article and/or as supplementary materials'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD; Head of the Department and Division of Medical Rehabilitation', 'investigatorFullName': 'Edyta Sutkowska', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}