Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 4:42 PM
Study NCT ID:
NCT06978569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'In addition to outcome assessors, the data analyst is blinded to the randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound surface area (cm²) at Week 12, adjusted for baseline wound size', 'timeFrame': 'Week 1 and 12', 'description': 'Wound surface area is measured as length × width (in cm²) using digital planimetry. Comparison of wound size between groups at Week 12 will be conducted using ANCOVA, adjusting for baseline wound size and relevant covariates.'}], 'secondaryOutcomes': [{'measure': 'Time to complete wound healing (100% epithelialization)', 'timeFrame': 'Weekly up to 12 weeks', 'description': 'Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.'}, {'measure': 'Rate of granulation tissue formation', 'timeFrame': 'Weekly up to 12 weeks', 'description': 'Visual and digital assessment of granulation tissue coverage over time.'}, {'measure': 'Rate of wound epithelialization', 'timeFrame': 'Weekly up to 12 weeks', 'description': 'Proportion of wound area covered by new epithelium, assessed at each follow-up visit.'}, {'measure': 'Incidence of complications (infection, necrosis, bleeding)', 'timeFrame': 'Up to 12 weeks', 'description': 'Number and type of wound-related adverse events recorded during follow-up.'}, {'measure': 'Quality of life score at Week 12', 'timeFrame': 'Weeks 1 and 12', 'description': 'Patient-reported quality of life is assessed using the SF-36 questionnaire at baseline and Week 12. Group differences at Week 12 will be analyzed using ANCOVA, adjusting for baseline SF-36 scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic wound', 'acellular dermal matrix', 'ADM', 'wound size', 'alginate'], 'conditions': ['Trauma Wounds']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to find out whether a wound treatment made from acellular dermal matrix (ADM) gel can help heal chronic traumatic wounds more effectively than standard alginate dressings in adults aged 18 and older with wounds that have lasted more than 3 weeks.\n\nThe main questions it aims to answer are:\n\nDoes ADM gel reduce the size of chronic wounds more than alginate dressings after 12 weeks?\n\nDoes ADM gel help wounds heal faster and improve quality of life for patients?\n\nResearchers will compare ADM gel to alginate dressings to see if the ADM gel leads to better healing results and fewer complications.\n\nParticipants will:\n\nBe randomly assigned to receive either ADM gel or alginate dressing.\n\nHave the treatment applied directly to their cleaned wound.\n\nAttend weekly visits for up to 12 weeks for wound checks, measurements, and dressing changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic trauma wounds persisting ≥3 weeks.\n* Wound size between 4 and 20 cm² and depth ≤9 mm on the lower limbs.\n* Willingness and ability to provide informed consent.\n* Wounds without uncontrolled infection\n\nExclusion Criteria:\n\n* Wounds with exposed bone.\n* Current use of immunomodulators, corticosteroids, immunosuppressive or cytotoxic drugs.\n* Pregnant individuals.\n* Significant reduction (≥30%) of wound size during a 2-week run-in phase.\n* Concurrent participation in another clinical trial involving drugs.\n* Wounds with uncontrolled infection\n* Allergy or hypersensitivity to components of ADM gel or alginate'}, 'identificationModule': {'nctId': 'NCT06978569', 'briefTitle': 'Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'A Randomized, Outcome Assessor-Blinded Clinical Trial Comparing the Efficacy of Acellular Dermal Matrix (ADM) Hydrogel Versus Alginate Dressings in the Treatment of Chronic Traumatic Wounds', 'orgStudyIdInfo': {'id': 'IR.ARI.MUI.REC.1404.054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADM hudrogel group', 'description': 'Participants in this group will receive an acellular dermal matrix (ADM) hydrogel applied directly to the wound bed following standard debridement procedures. After application, the wound will be covered with a standard secondary dressing. Dressing changes will be performed every 2 to 3 days, or as clinically indicated based on wound condition and healing progress.', 'interventionNames': ['Device: Injectable Acellular dermal matrix hydrogel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alginate Dressing Group', 'description': "Participants in this group will receive an alginate dressing applied directly to the wound bed following debridement. The wound will be managed with dressing changes performed according to the manufacturer's instructions and standard clinical protocol.", 'interventionNames': ['Device: Alginate dressing']}], 'interventions': [{'name': 'Injectable Acellular dermal matrix hydrogel', 'type': 'DEVICE', 'description': 'An injectable, sterile acellular dermal matrix (ADM) gel derived from processed biological tissue, designed to promote healing in chronic wounds. The gel is injected directly onto the wound bed following standard debridement and serves as a biocompatible scaffold to support granulation tissue formation, epithelialization, and wound closure. After application, the wound is covered with a standard secondary dressing. Dressing changes are performed every 2 to 3 days or as clinically indicated.', 'armGroupLabels': ['ADM hudrogel group']}, {'name': 'Alginate dressing', 'type': 'DEVICE', 'description': "A sterile, absorbent alginate wound dressing composed of natural polysaccharide fibers derived from seaweed. Following standard debridement, the alginate dressing is applied directly to the wound bed to manage exudate and maintain a moist wound environment conducive to healing. The dressing is covered with a secondary dressing and changed according to the manufacturer's instructions and clinical protocol.", 'armGroupLabels': ['Alginate Dressing Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'country': 'Iran', 'contacts': [{'name': 'Mehdi Rasti, MD, Clinical Fellowship', 'role': 'CONTACT', 'email': 'rasti@med.mui.ac.ir', 'phone': '+989133111659'}], 'facility': 'Alzahra hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'centralContacts': [{'name': 'Seyed MohammadReza Rahavi, PhD', 'role': 'CONTACT', 'email': 'mrahavi@gmail.com', 'phone': '+989123093989'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'accessCriteria': 'Individual participant data (IPD) underlying published results will be available upon reasonable request from qualified researchers with a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fateme Abedini', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}