[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07665268":3,"trial-entities:NCT07665268":138,"trial-summary:NCT07665268":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":58,"secondary_outcomes":63,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":14,"eligibility_criteria":79,"std_ages":105,"locations":108,"central_contacts":124,"overall_officials":131,"references":136,"see_also_links":137},"NCT07665268","Pro00092936","Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.","RECRUITING","2028-01-28","2026-06","2026-06-24","2026-01-28","Sequence LifeScience, Inc.","INDUSTRY",false,"A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.","This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing",[18,19,20,21,22,23],"Skin Ulcer","Pressure Ulcer (PU)","Pressure Ulcer of Skin","Pressure Sore","Chronic Ulcer","Pressure Wound",[25,26,27,21,18,20,22,28],"Ulcer","Pressure","Pressure Ulcer","Wound","INTERVENTIONAL","TREATMENT",[32],"PHASE4",{"count":34,"type":35},2000,"ESTIMATED",[37,42,46,50,54],{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Activate™ Matrix + SOC","Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.",[39],{"type":38,"name":43,"description":44,"armGroupLabels":45},"AmnioDefend™ FT Matrix + SOC","Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.",[43],{"type":38,"name":47,"description":48,"armGroupLabels":49},"Palisade™ DM Matrix + SOC","Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.",[47],{"type":38,"name":51,"description":52,"armGroupLabels":53},"Sentry™ SL Matrix + SOC","Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.",[51],{"type":38,"name":55,"description":56,"armGroupLabels":57},"Shelter™ DM Matrix + SOC","Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.",[55],[59],{"measure":60,"description":61,"timeFrame":62},"Between Arm Difference for Complete Closure","Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.","0-20 Weeks",[64,67,70,73],{"measure":65,"description":66,"timeFrame":62},"Time to Closure","Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.",{"measure":68,"description":69,"timeFrame":62},"Percentage Area Reduction","Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.",{"measure":71,"description":72,"timeFrame":62},"Pain Scale Reduction","Determine the between-arm difference in pain for patients that present with a Visual Analog Scale score of greater than 4. The scale is a rage of 0-10, 0 being no pain and 10 being worst pain imaginable.",{"measure":74,"description":75,"timeFrame":62},"Adverse Events","Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.","ALL","18 Years",null,{"inclusion":80,"exclusion":87,"raw_text":104},[81,82,83,84,85,86],"The potential subject must be at least 18 years of age or older.","The potential subject must agree to attend the weekly study visits required by the protocol.","The potential subject must be willing and able to participate in the informed consent process.","The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).","At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device.","The potential subject has adequate off-loading of the ulcer",[88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"The potential subject is known to have a life expectancy of \\\u003C 3 months.","The potential subject's target ulcer is not a pressure ulcer.","The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.","The target ulcer exposes tendon or bone.","The target ulcer has undermining or tunneling.","There is evidence of osteomyelitis complicating the target ulcer.","The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).","The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.","The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.","The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length × width is acceptable).","The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC. - The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.","The potential subject has end stage renal disease requiring dialysis.","The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.","The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.","The potential subject has a malnutrition indicator score of \\\u003C17 as measured on the Mini Nutritional Assessment.","Known hemoglobin of \\\u003C 8 g\u002FdL as this is an indicator of poor wound healing.","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n* The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device.\n* The potential subject has adequate off-loading of the ulcer\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 3 months.\n* The potential subject's target ulcer is not a pressure ulcer.\n* The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* The target ulcer has undermining or tunneling.\n* There is evidence of osteomyelitis complicating the target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length × width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC. - The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score of \\\u003C17 as measured on the Mini Nutritional Assessment.\n* Known hemoglobin of \\\u003C 8 g\u002FdL as this is an indicator of poor wound healing.",[106,107],"ADULT","OLDER_ADULT",[109],{"facility":110,"status":7,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":121},"Amber Stormer","North Royalton","Ohio","44133","United States",[116],{"name":117,"role":118,"phone":119,"email":120},"Amber Stormer, Admin","CONTACT","440-652-8748","astormer@encoreclinicalservices.com",{"lat":122,"lon":123},41.31366,-81.72457,[125,129],{"name":126,"role":118,"phone":127,"email":128},"Bennett Sarver","1-833-865-6300","info@serenagroups.com",{"name":130,"role":118,"phone":127,"email":128},"Amy Allen",[132],{"name":133,"affiliation":134,"role":135},"Thomas Serena, MD","Serena Group","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":139,"biomarkers":140},[21],[],{"nct_id":4,"found":142,"summary":143,"prompt_version":153},true,{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is a multi-center, prospective, modified platform trial involving 2000 participants. Participants will be randomly assigned to receive one of five treatments plus standard care.","completed","Study for Non-Healing Pressure Ulcers","This study is looking for 2000 adults aged 18 or older with non-healing pressure ulcers (also called pressure sores or bedsores) that are full-thickness stage 3 or 4. It's testing five different products: Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix, Sentry™ SL Matrix, and Shelter™ DM Matrix. Each product is given weekly along with standard care. The goal is to see which treatment helps the ulcers close completely within 20 weeks. You would need to attend weekly study visits. The study is currently recruiting participants.","Ulcer closure is assessed weekly, and confirmed 2 weeks after initial closure, up to a maximum of 20 weeks.",86,"You would receive weekly applications of one of the study treatments and standard of care for up to 20 weeks, or until your ulcer closes. You would also need to attend weekly study visits.","Not stated in the trial record.",[],"v2"]