Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-26 @ 11:54 AM
Study NCT ID:
NCT05577104
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wound Bed Preparation for Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients with diabetic foot ulcers (DFUs)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the time to STSG surgery', 'timeFrame': '3 months post debridement', 'description': 'the duration from first surgical debridement to STSG surgery'}], 'secondaryOutcomes': [{'measure': 'the wound blood perfusion', 'timeFrame': 'Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).', 'description': 'The blood perfusion of the DFUs wounds were evaluated by the laser speckle contrast imaging (LSCI) instrument. The higher value means a better outcome.'}, {'measure': 'the wound neutrophil extracellular traps (NETs) formation', 'timeFrame': 'Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).', 'description': 'The wound granulation tissues (1 mL) were collected from the DFU wound of patients. The wound granulation tissues were stained for NETs by immunofluorescence. Samples were stained with anti-human neutrophil elastase antibody and anti-human myeloperoxidase antibody. Visualization was performed with confocal microscopy. The higher number of NETs means a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot ulcers', 'negative pressure wound therapy', 'wound blood perfusion', 'neutrophil extracellular traps'], 'conditions': ['Diabetic Foot']}, 'referencesModule': {'references': [{'pmid': '30246926', 'type': 'RESULT', 'citation': 'Tettelbach W, Cazzell S, Sigal F, Caporusso JM, Agnew PS, Hanft J, Dove C. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Int Wound J. 2019 Feb;16(1):122-130. doi: 10.1111/iwj.13001. Epub 2018 Sep 24.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30246926/', 'label': 'Pubmed'}]}, 'descriptionModule': {'briefSummary': 'The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.', 'detailedDescription': 'The diabetic foot ulcers (DFUs) are major complications of patients with diabetes mellitus. Split thickness skin graft (STSG) surgery is a cost-effective method for the rapid healing of DFUs. The aim of this study was to compare the efficacy of negative pressure wound therapy (NPWT) using vacuum-assisted closure (VAC) device versus conventional moist dressings (alginates) on the wound bed preparation prior to STSG surgery for patients with chronic DFUs.\n\nThis ia a prospective, randomized controlled trial. All the patients were randomly divided into two groups: the NPWT group or the control group. Once the DFUs wound was filled with healthy granulation tissues, STSG surgery was performed. The primary endpoint included the time to STSG surgery (the duration from first surgical debridement to STSG surgery). The secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (NETs) formation, and polarization of M1 or M2 macrophages in the DFUs wounds of the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with DFUs aged 20-80 years.\n2. Wagner grade 2 to 3.\n3. Chronic DFUs wounds (duration of disease ≥ 2 weeks).\n4. Ankle brachial ratio (ABI) 0.5～0.9, wound area 8\\~20 cm2.\n\nExclusion Criteria:\n\n1. Patients who were unable to complete the follow-up were not included,\n2. Pregnant or nursing mothers were not included.\n3. Patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.\n4. Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.\n5. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included."}, 'identificationModule': {'nctId': 'NCT05577104', 'briefTitle': 'Wound Bed Preparation for Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'KY20220825-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the NPWT group', 'description': 'For patients in the NPWT group, the wound bed preparation was facilitated by VAC device.', 'interventionNames': ['Procedure: Negative pressure wound therapy (NPWT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the control group', 'description': 'For patients in the control group, the wound bed preparation was facilitated by alginates dressing change method.', 'interventionNames': ['Procedure: conventional moist dressings']}], 'interventions': [{'name': 'Negative pressure wound therapy (NPWT)', 'type': 'PROCEDURE', 'description': 'For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).', 'armGroupLabels': ['the NPWT group']}, {'name': 'conventional moist dressings', 'type': 'PROCEDURE', 'description': 'For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).', 'armGroupLabels': ['the control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yin Wu, phD', 'role': 'CONTACT', 'email': 'medwuyin@163.com', 'phone': '18305155832'}, {'name': 'Chao Hao, MD', 'role': 'CONTACT', 'email': 'haochao@163.com', 'phone': '15905166117'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yin Wu, phD', 'role': 'CONTACT', 'email': 'medwuyin@163.com', 'phone': '18305155832'}, {'name': 'Chao Hao, MD', 'role': 'CONTACT', 'email': 'cathywuyin@126.com', 'phone': '025-52271006'}], 'overallOfficials': [{'name': 'Yin Wu, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'url': 'http://www.stats.gov.cn/tjsj/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The data will become available on December,2023. The data will become available for 1 year.', 'ipdSharing': 'YES', 'description': 'The Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) are to be shared with other researchers.', 'accessCriteria': 'everyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital', 'investigatorFullName': 'YinWu', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}