Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-06 @ 11:30 AM
Study NCT ID:
NCT03755960
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2018-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACUpuncture in Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The statistician will be blinded to the study intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, open label, randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue Scale (VAS) general complaints and pain', 'timeFrame': '8 weeks', 'description': 'Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain'}], 'secondaryOutcomes': [{'measure': 'neuropathic pain symptom inventory (NPSI )', 'timeFrame': 'average of last 24h at baseline, 8, 16, 24 weeks', 'description': 'neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)'}, {'measure': '-diabetic peripheral neuropathic pain Impact measure (DPNPI)', 'timeFrame': 'average of last week at baseline, 8, 16, 24 weeks', 'description': 'disease- specific Quality of Life- max sum score of 95; the higher the sum-score the higher the interference of diabetic peripheral neuropathy with activities of daily living.'}, {'measure': 'Short-Form -12 (SF-12)', 'timeFrame': 'baseline , 8 weeks', 'description': '12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living'}, {'measure': 'pain perception Scale (SES german)', 'timeFrame': 'latest average at 8, 16, 24 weeks', 'description': 'emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience.'}, {'measure': 'Patient global impression of Change (PGIC)', 'timeFrame': '8, 16 and 24 weeks', 'description': 'Scale from 1= very much improved to 7= very much worse'}, {'measure': 'neurophysiological assessment of Nervus Suralis nerve conduction velocity', 'timeFrame': 'baseline, 8,16 and 24 weeks', 'description': 'measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®'}, {'measure': 'neurophysiological assessment of Nervus Suralis height of amplitude of action potential', 'timeFrame': 'baseline, 8,16 and 24 weeks', 'description': 'height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix®'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'peripheral neuropathy', 'diabetes mellitus type II', 'neurophysiology', 'nerve conduction velocity'], 'conditions': ['Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '18054725', 'type': 'BACKGROUND', 'citation': 'Weidenhammer W, Streng A, Linde K, Hoppe A, Melchart D. Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study. Complement Ther Med. 2007 Dec;15(4):238-46. doi: 10.1016/j.ctim.2006.09.005. Epub 2006 Oct 30.'}, {'pmid': '17355547', 'type': 'BACKGROUND', 'citation': 'Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x.'}, {'pmid': '19420954', 'type': 'BACKGROUND', 'citation': 'Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.'}, {'pmid': '40890741', 'type': 'DERIVED', 'citation': "Bolster M, Dietzel J, Habermann IV, Horder S, Brinkhaus B, Stockigt B. Patients' experiences with acupuncture for diabetic polyneuropathy as part of a randomized controlled trial (ACUDPN) - a qualitative study. BMC Complement Med Ther. 2025 Sep 1;25(1):317. doi: 10.1186/s12906-025-05064-w."}, {'pmid': '33637134', 'type': 'DERIVED', 'citation': 'Dietzel J, Horder S, Habermann IV, Meyer-Hamme G, Hahn K, Ortiz M, Roll S, Linde K, Irnich D, Hammes M, Nogel R, Wullinger M, Wortman V, Hummelsberger J, Willich SN, Schroder S, Brinkhaus B. Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial. Trials. 2021 Feb 26;22(1):164. doi: 10.1186/s13063-021-05110-1.'}]}, 'descriptionModule': {'briefSummary': 'Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.', 'detailedDescription': 'The study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of the affected nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria, among others:\n\n* Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2\n* Males and females aged \\>18yrs \\< 70yrs\n* Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)\n* Completed titration of pain medication against diabetic peripheral neuropathy\n* Pathological nerve conduction velocity and amplitude of N. suralis ( \\<42meter/second and or \\< 6 mikroVolt)\n\nExclusion Criteria, among others:\n\n* Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles\n* Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs.\n* Severe peripheral artery disease Fontaine stage IV\n* Ulcers or gangrenous lesions of the feet'}, 'identificationModule': {'nctId': 'NCT03755960', 'acronym': 'ACUDPN', 'briefTitle': 'ACUpuncture in Diabetic Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.', 'orgStudyIdInfo': {'id': 'ACUDPN'}, 'secondaryIdInfos': [{'id': '1/183/18', 'type': 'OTHER', 'domain': 'ethics committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture plus routine care', 'description': '12 session of semistandardized acupuncture together with pharmacological routine care', 'interventionNames': ['Procedure: acupuncture', 'Drug: routine care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routine care alone', 'description': 'pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)', 'interventionNames': ['Drug: routine care']}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'description': 'semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks', 'armGroupLabels': ['acupuncture plus routine care']}, {'name': 'routine care', 'type': 'DRUG', 'description': 'pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)', 'armGroupLabels': ['acupuncture plus routine care', 'routine care alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Campus Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Praxis für TCM am UKE', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Benno Brinkhaus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benno Brinkhaus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karl and Veronica Carstens Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benno Brinkhaus', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}