Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-04-16 @ 5:54 PM
Study NCT ID:
NCT02061059
Status:
UNKNOWN
Last Update Posted:
2014-02-12
First Post:
2014-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011115', 'term': 'Polyneuropathies'}], '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': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-11', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cost-effectiveness of shoes produced with and without plantar pressure measurements.', 'timeFrame': 'approximately 10 weeks (at delivery of the shoes)'}], 'secondaryOutcomes': [{'measure': 'Change in plantar pressure after wearing the therapeutic shoes for 3 months.', 'timeFrame': 'approximately 22 weeks (at follow-up)'}, {'measure': 'The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.', 'timeFrame': 'approximately 22 weeks (at follow-up)', 'description': 'The number of diabetic foot problems serves as an additional measure of the quality of the therapeutic shoes produced.'}, {'measure': 'Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes.', 'timeFrame': 'approximately 10 weeks (at delivery of the shoes)', 'description': 'Qualitative measure of differences in production process of the shoes produced with or without plantar pressure measurements.'}, {'measure': 'Differences in plantar pressures between the two shoes produced.', 'timeFrame': 'approximately 10 weeks (at delivery of the shoes)'}, {'measure': 'The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".', 'timeFrame': 'approximately 22 weeks (at follow-up)'}, {'measure': 'Differences in plantar pressures between the two shoes produced.', 'timeFrame': 'approximately 22 weeks (at follow-up)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Polyneuropathies']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.', 'detailedDescription': 'For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes\n* neuropathy\n* prescription of therapeutic footwear\n* diabetic foot ulcer in the last 5 years\n* receiving regular preventive foot care\n* written informed consent\n\nExclusion Criteria:\n\n* peripheral arterial disease\n* not motivated to wear therapeutic footwear\n* active foot ulcer\n* recent vascular intervention\n* severe mobility impairment\n* amputation more proximal than toes, except a single ray amputation is allowed.\n* severe visual impairment\n* active cancer\n* severe cardiac/ pulmonary failure\n* severe oedema\n* chronic drug abuse\n* severe psychiatric illness\n* hospital admission at the time of inclusion\n* any condition that may interfere with follow-up visits.'}, 'identificationModule': {'nctId': 'NCT02061059', 'briefTitle': 'Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device', 'orgStudyIdInfo': {'id': '13-1-112.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group 1', 'description': 'group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements.\n\ngroup is assigned to "standard": wears shoes produced with standard procedure', 'interventionNames': ['Other: block 1', 'Other: standard']}, {'type': 'OTHER', 'label': 'group 2', 'description': 'group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements\n\ngroup is assigned to "with measurements": wears shoes produced with plantar pressure measurements', 'interventionNames': ['Other: block 1', 'Other: with measurements']}, {'type': 'OTHER', 'label': 'group 3', 'description': 'group is assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements\n\ngroup is assigned to "standard": wears shoes produced with standard procedure', 'interventionNames': ['Other: block 2', 'Other: standard']}, {'type': 'OTHER', 'label': 'group 4', 'description': 'group assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements\n\ngroup is assigned to "with measurements": wears shoes produced with plantar pressure measurements', 'interventionNames': ['Other: block 2', 'Other: with measurements']}], 'interventions': [{'name': 'block 1', 'type': 'OTHER', 'description': 'shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements', 'armGroupLabels': ['group 1', 'group 2']}, {'name': 'block 2', 'type': 'OTHER', 'description': 'shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements', 'armGroupLabels': ['group 3', 'group 4']}, {'name': 'standard', 'type': 'OTHER', 'description': 'patient wears shoes produced with standard method', 'armGroupLabels': ['group 1', 'group 3']}, {'name': 'with measurements', 'type': 'OTHER', 'description': 'patient wears shoes produced with plantar pressure measurements', 'armGroupLabels': ['group 2', 'group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200MD', 'city': 'Maastricht', 'country': 'Netherlands', 'contacts': [{'name': 'Tom Melai, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6135 LE', 'city': 'Sittard', 'country': 'Netherlands', 'contacts': [{'name': 'Tom Melai, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Smeets Loopcomfort', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}], 'centralContacts': [{'name': 'Tom Melai, PhD', 'role': 'CONTACT', 'email': 'tom.melai@MaastrichtUniversity.nl', 'phone': '+31 43 3881398'}], 'overallOfficials': [{'name': 'Nicolaas C Schaper, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}, {'name': 'Hans H Savelberg, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}