Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 7:12 AM
Study NCT ID:
NCT01500668
Status:
UNKNOWN
Last Update Posted:
2012-01-05
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2011-12-27', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'index of Toe and Finger Ischemia (iTFI)', 'timeFrame': 'three months after drug administration', 'description': 'Score including:\n\nO2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration'}], 'secondaryOutcomes': [{'measure': 'Amputation', 'timeFrame': 'Three months after drug administration', 'description': 'Amputations performed - fingers, toe and limb - height and number of amputations'}, {'measure': 'Patients survival', 'timeFrame': 'Three months after drug administration', 'description': 'Survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Botox', 'catocholamine', 'shock', 'vasomotor', 'Vasopressin', 'botulinum toxin'], 'conditions': ['Catocholamine Induced Finger Necrosis']}, 'referencesModule': {'references': [{'pmid': '12771608', 'type': 'BACKGROUND', 'citation': 'Dunser MW, Mayr AJ, Tur A, Pajk W, Barbara F, Knotzer H, Ulmer H, Hasibeder WR. Ischemic skin lesions as a complication of continuous vasopressin infusion in catecholamine-resistant vasodilatory shock: incidence and risk factors. Crit Care Med. 2003 May;31(5):1394-8. doi: 10.1097/01.CCM.0000059722.94182.79.'}, {'pmid': '19258141', 'type': 'BACKGROUND', 'citation': "Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud's phenomenon. J Hand Surg Am. 2009 Mar;34(3):446-52. doi: 10.1016/j.jhsa.2008.11.026."}, {'pmid': '7359665', 'type': 'BACKGROUND', 'citation': 'Golbranson FL, Lurie L, Vance RM, Vandell RF. Multiple extremity amputations in hypotensive patients treated with dopamine. JAMA. 1980 Mar 21;243(11):1145-6.'}, {'pmid': '17255677', 'type': 'BACKGROUND', 'citation': 'Van Beek AL, Lim PK, Gear AJL, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007 Jan;119(1):217-226. doi: 10.1097/01.prs.0000244860.00674.57.'}, {'pmid': '21855233', 'type': 'BACKGROUND', 'citation': 'Janz BA, Thomas PR, Fanua SP, Dunn RE, Wilgis EF, Means KR Jr. Prevention of anastomotic thrombosis by botulinum toxin B after acute injury in a rat model. J Hand Surg Am. 2011 Oct;36(10):1585-91. doi: 10.1016/j.jhsa.2011.07.008. Epub 2011 Aug 19.'}, {'pmid': '19116537', 'type': 'BACKGROUND', 'citation': 'Clemens MW, Higgins JP, Wilgis EFS. Prevention of anastomotic thrombosis by botulinum toxin a in an animal model. Plast Reconstr Surg. 2009 Jan;123(1):64-70. doi: 10.1097/PRS.0b013e3181904c31.'}]}, 'descriptionModule': {'briefSummary': 'Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with vasoactive drugs (amines) and have finger/toe necrosis\n\nExclusion Criteria:\n\n* Sensitivity to drug (Botox) ingredients.\n* Active local limb infection\n* ICU admission due to botulism\n* Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS\n* Age lower than 18'}, 'identificationModule': {'nctId': 'NCT01500668', 'briefTitle': 'Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.', 'orgStudyIdInfo': {'id': 'SHEBA-11-9023-AH-CTIL'}, 'secondaryIdInfos': [{'id': '9023-11-SMC', 'type': 'OTHER_GRANT', 'domain': 'Sheba medical center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.', 'interventionNames': ['Drug: Botox']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'description': 'Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amir Herman, MD, PhD', 'role': 'CONTACT', 'email': 'amirherm@gmail.com', 'phone': '972-52-2655026'}, {'name': 'Amir Herman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Amir Herman, MD, PhD', 'role': 'CONTACT', 'email': 'amirherm@gmail.com', 'phone': '972-52-2655026'}], 'overallOfficials': [{'name': 'Amir Herman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Amir Herman', 'investigatorAffiliation': 'Sheba Medical Center'}}}}