Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT00292357
Status:
UNKNOWN
Last Update Posted:
2010-01-18
First Post:
2006-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2010-01-15', 'studyFirstSubmitDate': '2006-02-14', 'studyFirstSubmitQcDate': '2006-02-14', 'lastUpdatePostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Feasibility'}, {'measure': 'Healing velocity'}]}, 'conditionsModule': {'conditions': ['Diabetic Foot', 'Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus\n* chronic non-healing foot ulcers (\\>4weeks)\n\nExclusion Criteria:\n\n* Charcot foot\n* Non-diabetic ulcers\n* Ulcers healing under conventional therapy\n* Sepsis\n* Hematologic disorders\n* Pregnancy\n* Acute inflammatory disorders\n* Chemotherapy'}, 'identificationModule': {'nctId': 'NCT00292357', 'briefTitle': 'Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'orgStudyIdInfo': {'id': 'HD-Med1-01/06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Application of autologous bone marrow', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Per M Humpert, MD', 'role': 'CONTACT', 'email': 'per.humpert@med.uni-heidelberg.de', 'phone': '+49 6221 56', 'phoneExt': '8787'}], 'facility': 'Medizinische Klinik 1, Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Per Humpert, MD', 'role': 'CONTACT', 'email': 'per.humpert@med.uni-heidelberg.de', 'phone': '+49 6221 56', 'phoneExt': '8787'}], 'overallOfficials': [{'name': 'Peter Nawroth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, Dept. Medicine 1, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}