[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-ulcers-stage-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-ulcers-stage-ii":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100646107","evaluating-the-efficacy-of-a-tocotrienols-loaded-dressing-in-wound-care-for-pressure-ulcers-100646107",false,"NCT07694583","Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers","A Prospective, Double-Blinded, Randomized Controlled Trial to Evaluate the Efficacy of a Formulated Dressing Containing Tocotrienols in Wound Care for Pressure Ulcers","TOCOWO","Inclusion Criteria:\n\n* The included participants or caretakers are older than 18 years with at least one pressure ulcer that was stage I-II as classified by the National Pressure Ulcer Advisory Panel and the European Pressure Ulcer Advisory Panel (NPUAP\u002FEPUAP)\n* Exhibited a pressure ulcer surface area of \\\u003C80 cm2 (multiplication of the major and minor diameters of the wound surface)\n* PUSH (version 3.0) score of \\>5 that was likely to heal during the 6-month study period\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Stage III \\& IV pressure ulcers requiring different standard of care\n* Multiple known allergies to other types of dressings\n* Wound deemed to have an infection\n* Area of skin necrosis that requires special dressing and\u002For topical antibiotic treatment\n* Any (medical) conditions that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects' successful completion of the clinical trial\n* Allergic to dressings during 24-hour pre-study allergy test","ALL","18 Years",{"count":20,"type":21},114,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to investigate the effects of the dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. The main questions it aims to answer are:\n\n* Will the dressing containing Tocotrienols lead to a reduction in the Pressure Ulcer Scale for Healing (PUSH) Score?\n* Will the dressing containing Tocotrienols help heal the participants' pressure ulcer wounds?\n* Will the dressing containing Tocotrienols lead to reduction in wound surface area?\n* What is the percentage of patients with completely healed wounds by the end of the study?\n\nResearchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers.\n\nParticipants will:\n\n* Have their pressure ulcers checked by a study doctor to ensure they are infection-free and suitable ulcer fitting the inclusion criteria\n* Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing\n* Be randomly assigned to one of three groups if they qualify: control, vehicle-control, or treatment group\n* Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing.\n* Attend follow-up visits on days 1, 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.",[27,28,29],"Pressure Ulcer Stage 1","Pressure Ulcers Stage II","Pressure Injuries",[31,32,33,34,35,36,37,38],"Dressing membrane","Tocotrienols","Wound care","Pressure Ulcer","hydrocolloid","pressure injury","PUSH score","wound size reduction","RECRUITING","2026-07-13",{"date":42,"type":43},"2026-07-15","ACTUAL",{"date":45,"type":43},"2026-01-21",{"date":47,"type":21},"2027-12",{"name":49,"class":50},"Monash University Malaysia","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100477386","comparison-of-transforming-powder-dressing-to-npiap-recommended-standard-of-care-therapies-in-stage-2-3-and-4-pressure-injuries-100477386","NCT05496296","Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries","Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries","Inclusion Criteria:\n\n1. 18 to 85 years of age;\n2. Stage 2, 3, or 4 Pressure Injuries;\n3. Wound exudate is mild to moderate;\n4. No clinically active wound infection (clinical diagnosis);\n5. Able and willing to provide written (not proxy) informed consent;\n6. Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to TPD or its components;\n2. Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;\n3. Heavily exudative wounds;\n4. Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema \\>0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;\n5. Poorly controlled diabetes with HgbA1C \\>12 (as documented in the last 3 months);\n6. Body Mass Index (BMI) \\>45 kg\u002Fm2;\n7. Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);\n8. Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \\\u003C0.7 on the affected limb, if wound is located on the limb);\n9. Received immunosuppression or biologics in the last six weeks and\u002For is expected to receive either at any point during the study;\n10. Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;\n11. Wounds with necrosis unable to undergo prior definitive debridement;\n12. Fistulas;\n13. Active gangrene;\n14. Untreated HIV;\n15. Currently pregnant or lactating;\n16. Impending organ transplant;\n17. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;\n18. Unwilling or unable to comply with offloading recommendations;\n19. If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:\n\n    1. Unable to keep research appointments;\n    2. Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);\n    3. Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;\n    4. Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;\n    5. Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;\n    6. Not suitable for study participation. -",true,"85 Years",{"count":62,"type":21},300,[24],"Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a \"dressing, wound, hydrogel\" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.",[28,66,67],"Pressure Ulcers Stage III","Pressure Ulcer, Stage IV",[33,69,70],"Quality of life","Pain","2025-11-17",{"date":73,"type":43},"2025-11-20",{"date":75,"type":43},"2023-04-30",{"date":77,"type":21},"2026-12",{"name":79,"class":80},"ULURU Inc.","INDUSTRY",14,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100607845","phase-4-zinc-oxide-vs-mebo-100607845","NCT07193849","Zinc Oxide VS MEBO","Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial","Inclusion Criteria:\n\n* Willing to participate.\n* KAMC cases in medical ward, neuroscience ward, and intensive care unit.\n* Newly cases diagnosed with second stage pressure ulcer according to the European pressure ulcer advisory panel\u002Fnational pressure ulcer advisory panel (NPUAP) guidelines.\n\nExclusion Criteria:\n\n* Not consenting to participate\n* Patients with suspected hypersensitivity reactions to any of the topical formulation's ingredients.\n* Either a category III or IV pressure ulcer.\n* Evidence of deep tissue injury (exudative drainage, purple or maroon localized area of discolored intact skin or blood-filled blister due to pressure damage).\n* Signs of wound infection (pus draining from the ulcer, a foul-smelling odour, tenderness, heat and increased redness in the surrounding skin and fever).\n* Patients who undertaking other therapies that could affect healing, such as corticosteroids, radiation therapy, or chemotherapy for cancer.\n* Heavy smoking (more than 20 cigarettes a day).\n* Concomitant chronic disease (e.g., diabetes mellitus or frank vascular disease such as Buerger's disease).\n* Patients who unable to continue the study because of death, discharge, or change in the care setting.",{"count":90,"type":21},76,[92],"PHASE4","randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.",[95,96,97,28,98],"Pressure Injury","Pressure Injury Stage 2","Bedsore","Pressure Ulcer, Buttock",[36,100,101,102],"pressure ulcer","MEBO","Zinc oixid","2025-09-22",{"date":105,"type":43},"2025-09-26",{"date":107,"type":43},"2023-12-31",{"date":109,"type":21},"2025-12-31",{"name":111,"class":112},"King Abdullah Medical City","OTHER_GOV",2]