[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-sore\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-sore":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,72],{"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":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":49},"100485232","phase-4-npwti-on-closure-of-chronic-pressure-sores-100485232","NCT05598398","NPWTi on Closure of Chronic Pressure Sores","Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Ischial and sacral wounds at stage 3 and 4.\n2. Any pressure sore that has the potential for a good seal.\n\nExclusion Criteria:\n\n1. Any pressure sore that does not have potential for a good seal.\n2. Patients with fecal incontinence (due to potential for pressure sore to be near the anus).\n3. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).\n4. Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.",{"count":58,"type":20},62,[23],"The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.",[29],"2026-03-23",{"date":64,"type":41},"2026-03-25",{"date":66,"type":41},"2022-09-26",{"date":68,"type":20},"2027-05",{"name":70,"class":71},"Northwestern University","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100544500","ideal-skiin-cares-bundle-to-prevent-pressure-injury-100544500","NCT06369688","IDEAL SKIIN CARES Bundle to Prevent Pressure Injury","Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial","IdealSkinCares","Inclusion Criteria:\n\n* be adults aged 18 years or older;\n* have been hospitalized for a minimum of 48 hours;\n* be willing to participate.\n\nExclusion Criteria:\n\n* patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;\n* have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);\n* be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);\n* individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;\n* patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;\n* admitted to the hospital for \\>28 days;\n* those with prior experience of PIs or training in PIs care and prevention.",true,"90 Years",{"count":83,"type":20},1620,[85],"NA","The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.",[35,88,89,29,90,91,26],"Pressure Injury","Bed Sore","Decubitus Sore","Decubitus Ulcer",[88,93,94,95,96],"Care Bundle","Hospital-acquired pressure injury","Randomized Clinical Trial","IDEAL SKIIN CARES","NOT_YET_RECRUITING","2024-04-15",{"date":100,"type":41},"2024-04-17",{"date":102,"type":20},"2025-10-01",{"date":104,"type":20},"2027-10-01",{"name":106,"class":71},"Baqiyatallah Medical Sciences University"]