Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-30 @ 5:21 AM
Study NCT ID:
NCT03020368
Status:
TERMINATED
Last Update Posted:
2019-02-12
First Post:
2017-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D024763', 'term': 'Leeching'}, {'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Expectation', 'timeFrame': 'Baseline', 'description': '5-stage Likert scale for the expectation of symptomatic efficacy after group assignment'}, {'measure': 'Overall assessment of efficacy and tolerability', 'timeFrame': 'Day 56', 'description': '5-stage Likert scale documented by the patient as well as by the doctor at the end of the study'}], 'primaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder and Hand (DASH)', 'timeFrame': 'Change after 28 and 56 days'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Change after 7, 28 and 56 days'}, {'measure': 'Medication on demand', 'timeFrame': 'Documentation between baseline and day 56', 'description': 'Documentation in daily diary'}]}, 'conditionsModule': {'conditions': ['Rhizarthrosis']}, 'descriptionModule': {'briefSummary': 'In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 35 to 85 years\n* Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours)\n* Complaints for at least 3 months\n* X-ray Stadium Eaton I-IV at least once secured\n\nExclusion Criteria:\n\n* Anticoagulation (Marcumar, Heparin)\n* Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies\n* Combination therapy of ASA and thienopyridines\n* Pain medication with opioid analgesics\n* Systemic medication with corticoids or immunosuppressants\n* Intraarterticular injections or RSO within the last 3 months\n* Past or planned surgery on the affected joint in the next 2 months\n* Pregnancy, lactation\n* Insulin-dependent type I diabetes mellitus\n* Acute psychotic disorders\n* Severe comorbidity'}, 'identificationModule': {'nctId': 'NCT03020368', 'briefTitle': 'Effectiveness and Safety of Breeded Leech for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effectiveness and Safety of Breeded Leech "Medileech" by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Leeches for Rhizarthrosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leeches', 'description': 'One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base', 'interventionNames': ['Biological: Leeches']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diclofenac', 'description': '3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks', 'interventionNames': ['Drug: Diclofenac']}], 'interventions': [{'name': 'Leeches', 'type': 'BIOLOGICAL', 'otherNames': ['Hirudo verbana'], 'armGroupLabels': ['Leeches']}, {'name': 'Diclofenac', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14109', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Michalsen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Centrum Epidemiologie und Gesundheitsökonomie, CC1: Gesundheitswissenschaften'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}