Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 12:44 PM
Study NCT ID:
NCT00858351
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2009-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Biofeedback for the Treatment of Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2009-03-06', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Pain', 'timeFrame': 'Change in subjective pain rating from baseline to end of intervention'}], 'secondaryOutcomes': [{'measure': 'Perceived Control', 'timeFrame': 'Change from mid-intervention (visit 4) to end of intervention'}, {'measure': 'Temperature', 'timeFrame': 'Change within each session and across sessions from baseline to end of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Neuropathy', 'Peripheral', 'Painful', 'Thermal', 'Temperature', 'Biofeedback', 'Relaxation', 'Diabetic'], 'conditions': ['Diabetic Neuropathy, Painful']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine potential treatment options for a condition in diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as diabetic peripheral neuropathy.', 'detailedDescription': 'Participants attend 6 sessions lasting from 35 minutes to 2 hours (depending on the session). Sessions can be scheduled once or twice per week. Sessions involve a walking task, filling out questionnaires, and having temperature of hands and feet monitored. This study involves no drugs, blood draws, or any other invasive procedures. Participants are urged to continue the treatment of diabetes and diabetic neuropathy as directed by their physician for the duration of their involvement with the study. After 3 months, a packet of questionnaires will be mailed with a stamped addressed envelope to be returned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet\n* Must have some sensation left in hands and feet\n\nExclusion Criteria:\n\n* Any partial or total amputation of an limb or digit\n* Any previous experience with biofeedback\n* Prior treatment for alcohol abuse\n* Severe Psychopathology'}, 'identificationModule': {'nctId': 'NCT00858351', 'briefTitle': 'Thermal Biofeedback for the Treatment of Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms', 'orgStudyIdInfo': {'id': '200.97PY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermal Biofeedback Assisted Relaxation', 'interventionNames': ['Behavioral: Thermal Biofeedback Assisted Relaxation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Discussion', 'interventionNames': ['Behavioral: Discussion with therapist']}], 'interventions': [{'name': 'Thermal Biofeedback Assisted Relaxation', 'type': 'BEHAVIORAL', 'description': '6 sessions, 25 minutes in duration of relaxation and imagery training while temperature of hands and feet are recorded.', 'armGroupLabels': ['Thermal Biofeedback Assisted Relaxation']}, {'name': 'Discussion with therapist', 'type': 'BEHAVIORAL', 'description': '6 sessions, 25 minutes each, discussing topics with a therapist.', 'armGroupLabels': ['Discussion']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insulin Dependent Diabetes Trust', 'class': 'UNKNOWN'}, {'name': 'American Pain Society', 'class': 'OTHER'}, {'name': 'Rosalind Franklin University of Medicine and Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Fellow', 'investigatorFullName': 'Angela Fidler Pfammatter, PhD', 'investigatorAffiliation': 'Northwestern University'}}}}