Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-26 @ 11:39 PM
Study NCT ID:
NCT01137903
Status:
UNKNOWN
Last Update Posted:
2010-06-07
First Post:
2010-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-04', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of healing patients', 'timeFrame': '12 weeks', 'description': 'Number of diabetic foot ulcers healing in both arms.'}], 'secondaryOutcomes': [{'measure': 'Reulceration', 'timeFrame': '1 year after healing', 'description': 'Analysis of re-ulceration events in both arms after healing in a 1 year follow-up'}, {'measure': 'Healing time', 'timeFrame': '12 weeks', 'description': 'Healing time in both arms'}, {'measure': 'Complications', 'timeFrame': '12 weeks', 'description': 'Percentage of complications in both arms'}, {'measure': 'Quality of life', 'timeFrame': '12 weeks', 'description': 'Quality of life related to health in both arms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic foot', 'Osteomyelitis', 'Diabetic foot ulcers', 'Foot infections'], 'conditions': ['Osteomyelitis', 'Diabetic Foot', 'Diabetic Foot Ulcers']}, 'referencesModule': {'references': [{'pmid': '24130347', 'type': 'DERIVED', 'citation': 'Lazaro-Martinez JL, Aragon-Sanchez J, Garcia-Morales E. Antibiotics versus conservative surgery for treating diabetic foot osteomyelitis: a randomized comparative trial. Diabetes Care. 2014;37(3):789-95. doi: 10.2337/dc13-1526. Epub 2013 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.Material and Methods: Randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. It will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Diabetes Mellitus Type 1 or 2.\n* Patients with diabetic foot ulcers.\n* Patients with clinical suspects of osteomyelitis.\n* Patients with positive probe to bone test.\n* Patients with signs of osteolysis in the bone located adjacent to the ulcer in X-Ray\n* Patients with transcutaneous oxygen oxygenation above 30 mmHg.\n* Acceptance to participate in the study through prior informed consent.\n\nExclusion Criteria:\n\n* Patients with osteomyelitis associated with necrotizing soft tissue infections.\n* Presence of necrotic tissue in the wound bed, edges or margins of the lesion.\n* HbAc1 \\> 10.\n* Presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection.\n* Patients with bone exposure through the ulcer.\n* Patients with absent pulses, ankle/brachial index (ABI) \\<0.8 and TcPO2 \\<30 mmHg.\n* Pregnancy.\n* Allergies to antibiotics.\n* Any degree of renal impairment that contraindicated the administration of antibiotics proposed.\n* Hepatic insufficiency.\n* Mental Illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion."}, 'identificationModule': {'nctId': 'NCT01137903', 'briefTitle': 'Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'OM-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients undergoing medical treatment', 'description': 'Antibiotic treatment within 90 days with:\n\nCiprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.', 'interventionNames': ['Drug: Ciprofloxacin', 'Drug: Amoxicillin-Potassium Clavulanate Combination', 'Drug: Sulfamethoxazole trimethoprim']}, {'type': 'OTHER', 'label': 'Patients undergoing surgical treatment', 'description': 'Conservative surgical Minor amputation 7 days antibiotic after surgical', 'interventionNames': ['Procedure: Conservative surgery']}], 'interventions': [{'name': 'Conservative surgery', 'type': 'PROCEDURE', 'description': 'Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy', 'armGroupLabels': ['Patients undergoing surgical treatment']}, {'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': '500 mg/ 12 hours during 90 days', 'armGroupLabels': ['Patients undergoing medical treatment']}, {'name': 'Amoxicillin-Potassium Clavulanate Combination', 'type': 'DRUG', 'description': '875/125 mg/12 hours during 90 days', 'armGroupLabels': ['Patients undergoing medical treatment']}, {'name': 'Sulfamethoxazole trimethoprim', 'type': 'DRUG', 'description': 'Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.', 'armGroupLabels': ['Patients undergoing medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Luis Lázaro Martínez, PhD', 'role': 'CONTACT', 'email': 'diabetes@enf.ucm.es', 'phone': '+34913942203'}, {'name': 'Esther Alicia García Morales, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Silvia Allas Aguado, DP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Máximo Antonio González Jurado, RN, DP, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gabriel Rivera San Martín, DP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'María del Carmen García Carrión, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juan Vicente Beneit Montesinos, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'José Luis Lázaro Martínez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Franciso Javier Aragón Sánchez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Almudena Cecilia Matilla, DP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yolanda García Álvarez, RN, DP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'José Luis Lázaro Martínez', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'José Luis Lázaro Martínez, PhD', 'role': 'CONTACT', 'email': 'diabetes@enf.ucm.es', 'phone': '+34913942203'}], 'overallOfficials': [{'name': 'José Luis Lázaro Martínez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}, {'name': 'Francisco Javier Aragón Sánchez, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital La Paloma Las Palmas de Gran Canaria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'José Luis Lázaro Martínez/Professor', 'oldOrganization': 'Universidad Complutense de Madrid'}}}}