Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 5:04 AM
Study NCT ID:
NCT00448903
Status:
COMPLETED
Last Update Posted:
2011-03-17
First Post:
2007-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C411345', 'term': 'bemiparin'}, {'id': 'C079672', 'term': 'Ro 11'}, {'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-16', 'studyFirstSubmitDate': '2007-03-15', 'studyFirstSubmitQcDate': '2007-03-16', 'lastUpdatePostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total healing with intact skin or a significant improvement defined as a reduction of ulcer area > or = 50% or one degree reduction on Wagner Classification.', 'timeFrame': '90 day'}], 'secondaryOutcomes': [{'measure': 'incidence of major bleeding and the incidence of adverse events.', 'timeFrame': '210 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic', 'foot', 'ulcer', 'bemiparin', 'neuropathy', 'neuroishemic', 'diabetes'], 'conditions': ['Foot Ulcer, Diabetic']}, 'descriptionModule': {'briefSummary': 'Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes and often causes lower-extremity amputation. The aim of this study is to evaluate the effect of bemiparin as treatment of diabetic foot ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old who have given their informed consent to participate in the study.\n* Patients with type I or II Diabetes Mellitus (ADA Criteria).\n* Presence of chronic neuropathic inframalleolar diabetic foot ulcer (starting at least 2 months before), grade I or II on Wagner Classification, without significant improvement (reduction of ulcer area \\> or = 25%) within the past 15 days prior to inclusion.\n* Ulcer size equal or bigger than 0.64 cm2 using the following formula: \\[Major axis\\] x \\[Minor axis\\]\n* Ankle-brachial index (ABI) \\> or = 0,7\n\nExclusion Criteria:\n\n* Patients with clinical symptoms of limb-threatening or life-threatening infection\n* Presence of bone exposure at the bottom of the ulcer and/or bone palpation by catheter and/or presence of radiological signs of pathological fractures and/or bone sequesters\n* Ankle-brachial index (ABI) \\<0,7\n* Subjects with arterial calcification (ABI \\> 1,3) with negative tibial and foot pulse that for any cause the Toe/Arm index (T/A) cannot be measured by plethysmography (photoplethysmography or strain-gauge)\n* Subjects with arterial calcification (ABI \\> 1,3) with negative tibial and foot pulse and with T/A index \\< 0,55 measured by plethysmography (photoplethysmography or strain-gauge)\n* Patients with hematological disorders, organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms), severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).\n* Patients with severe renal failure (creatinine clearance \\<30 ml/min) or hepatic insufficiency (AST and/or ALT values \\>5 times the normal value established by the reference ranges of the local hospital laboratory).\n* Patients with connective tissue disease\n* Acute bacterial endocarditis or slow endocarditis.\n* Patients with antithrombin deficit and C and S protein deficit.\n* Patients with HbA1C \\> 12%.\n* Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.\n* Known hypersensitivity to LMWH, heparin or substances of porcine origin.\n* Patients with a history of heparin-induced thrombocytopenia.\n* Patients on treatment with anticoagulant therapy at inclusion time or in the past 15 days.\n* Patients on treatment with pentoxifiline at inclusion time or in the past 30 days.\n* Patients on treatment with systemic corticosteroid or immunosuppressive therapy at inclusion time or in the past 3 months.\n* Patients on treatment with beclapermin at inclusion time or in the past 15 days.\n* Patients that have suffered a revascularization or endovascular surgery two months prior to inclusion\n* Patients with a life expectancy less than 6 months.\n* Patients that cannot complete the scheduled follow-up visits or are not able to complete the study period.\n* Patients who are participating in another clinical trial or have done it in the past 30 days.'}, 'identificationModule': {'nctId': 'NCT00448903', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rovi Pharmaceuticals Laboratories'}, 'officialTitle': 'Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'ROV-BEM-2006-01'}, 'secondaryIdInfos': [{'id': '2006-005201-60'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Bemiparin', 'interventionNames': ['Drug: Bemiparin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bemiparin', 'type': 'DRUG', 'otherNames': ['RO-11', 'Hibor', 'Zibor', 'Ivor', 'Badyket', 'Ivorat', 'Ivormax', 'Entervit'], 'description': 'Bemiparin sodium', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sodium Chloride', 'physiological saline'], 'description': 'Sodium Chloride 0,9%', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagreb', 'country': 'Croatia', 'facility': 'CROATIA', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'POLAND', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'ROMANIA', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'RUSSIA', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'SERBIA', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'SPAIN', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'JR March, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Getafe Hospital, E-28905 Getafe (Madrid) Spain'}, {'name': 'J Marinel-lo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mataró Hospital, E-08304 Mataro (Barcelona) Spain'}, {'name': 'R Gómez Medialdea, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Virgen de la Victoria Hospital, E-29010 Malaga, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rovi Pharmaceuticals Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rovi Pharmaceuticals Laboratories', 'oldOrganization': 'Medical Department'}}}}