[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-ulcer-of-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-ulcer-of-skin":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100644245","phase-4-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-100644245",false,"NCT07665268","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.","RESTORE","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.","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","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.",[26,27,28,29,30,31],"Skin Ulcer","Pressure Ulcer (PU)","Pressure Ulcer of Skin","Pressure Sore","Chronic Ulcer","Pressure Wound",[33,34,35,29,26,28,30,36],"Ulcer","Pressure","Pressure Ulcer","Wound","RECRUITING","2026-06-17",{"date":40,"type":41},"2026-06-24","ACTUAL",{"date":43,"type":41},"2026-01-28",{"date":45,"type":20},"2028-01-28",{"name":47,"class":48},"Sequence LifeScience, Inc.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100576821","polyurethane-foam-pink-pad-rct-use-in-or-100576821","NCT06790277","Polyurethane Foam-Pink Pad (RCT) Use in OR","Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial","pink-pad","Inclusion Criteria:\n\n* Subjects ≥ 18.\n* Willing to participate.\n* Patients undergoing cardiac surgery.\n* Patient who is at risk for PU development as measured with Braden scale.\n* Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical judgement.\n\nExclusion Criteria:\n\n* Subjects under 17\n* Not consenting to participate\n* Patients with suspected hypersensitivity reactions to any of the dressing formulation's ingredients.\n* Patients who are unable to continue the study because of death or change in the care setting.",{"count":59,"type":20},100,[61],"NA","King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.",[64,65,28,35],"Cardiac Surgery Subjects","Pressure Ulcer Prevention",[67,68,69,70,71],"five layers sacral foam dressing","PINK PAD","pressure ulcers","Patients undergoing cardiac surgery","Mepilex dressing","2025-01-21",{"date":74,"type":41},"2025-01-24",{"date":76,"type":41},"2023-10-10",{"date":78,"type":20},"2025-10-10",{"name":80,"class":81},"King Abdullah Medical City","OTHER_GOV"]