Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-08 @ 12:26 PM
Study NCT ID:
NCT01948934
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2013-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-24', 'studyFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serious adverse events', 'timeFrame': '12 months'}, {'measure': 'inflammatory changes', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'wound evaluation', 'timeFrame': '12 months', 'description': 'inflammatory condition of the wound,surface,'}, {'measure': 'immunological evaluation', 'timeFrame': '12 months', 'description': 'anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection'}, {'measure': 'histological evaluation', 'timeFrame': '12 months', 'description': 'Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy'}, {'measure': 'microbiological evaluation', 'timeFrame': '12 months', 'description': 'microbiological culture'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Skin', 'Injury', 'Membrane amniotic', 'Wound'], 'conditions': ['Wound']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds', 'detailedDescription': 'Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute wounds in granulation phase with a minimum surface of 100cm2\n* ≥ 18 years\n* signing informed consent form\n* guarantee adherence to protocol\n\nExclusion Criteria:\n\n* chronic arterial insufficiency\n* pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method\n* involved in other assay\n* previous disease; kidney, heart, hepatic, systemic or immune\n* inability to understand informed consent form"}, 'identificationModule': {'nctId': 'NCT01948934', 'briefTitle': 'Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia'}, 'officialTitle': 'Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds', 'orgStudyIdInfo': {'id': 'MA/GH'}, 'secondaryIdInfos': [{'id': '2011-004395-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amniotic membrane in big wounds', 'description': 'The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue', 'interventionNames': ['Procedure: Amniotic membrane in big wounds']}], 'interventions': [{'name': 'Amniotic membrane in big wounds', 'type': 'PROCEDURE', 'description': 'The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue', 'armGroupLabels': ['amniotic membrane in big wounds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'state': 'El Palmar', 'country': 'Spain', 'facility': 'Gregorio Castellanos Escrig MD', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Gregorio Castellanos Escrig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinico Universitario Virgen de la Arrixca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}