[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591295":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Isfahan University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ADM hudrogel group","EXPERIMENTAL","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.",[13],"Device: Injectable Acellular dermal matrix hydrogel",{"label":15,"type":16,"description":17,"interventionNames":18},"Alginate Dressing Group","ACTIVE_COMPARATOR","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.",[19],"Device: Alginate dressing",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Injectable Acellular dermal matrix hydrogel","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Alginate dressing","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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Seyed MohammadReza Rahavi, PhD","CONTACT","+989123093989","mrahavi@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Alzahra hospital","Isfahan","Iran","IR",{"type":44,"coordinates":45},"Point",[46,47],51.67462,32.65246,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":52,"phoneExt":26,"email":53},"Mehdi Rasti, MD, Clinical Fellowship","+989133111659","rasti@med.mui.ac.ir",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Fateme Abedini","Principal Investigator","100591295","comparative-efficacy-of-adm-hydrogel-vs-alginate-dressings-in-chronic-trauma-wounds-100591295",false,"NCT06978569","Comparative Efficacy of ADM Hydrogel vs. Alginate Dressings in Chronic Trauma Wounds","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","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","ALL","18 Years","65 Years",{"count":69,"type":70},130,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.",[76],"Trauma Wounds",[78,79,80,81,82],"chronic wound","acellular dermal matrix","ADM","wound size","alginate","NOT_YET_RECRUITING","2025-05-11",{"date":86,"type":87},"2025-05-18","ACTUAL",{"date":89,"type":70},"2025-07",{"date":91,"type":70},"2026-09",{"name":5,"class":6},1]