[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ULURU Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100477386","comparison-of-transforming-powder-dressing-to-npiap-recommended-standard-of-care-therapies-in-stage-2-3-and-4-pressure-injuries-100477386",false,"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,"ALL","18 Years","85 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30],"Pressure Ulcers Stage II","Pressure Ulcers Stage III","Pressure Ulcer, Stage IV",[32,33,34],"Wound care","Quality of life","Pain","RECRUITING","2025-11-17",{"date":38,"type":39},"2025-11-20","ACTUAL",{"date":41,"type":39},"2023-04-30",{"date":43,"type":22},"2026-12",{"name":45,"class":46},"ULURU Inc.","INDUSTRY",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100471859","phase-4-acute-partial-thickness-burn-study-comparing-transforming-powder-dressing-to-standard-of-care-dressing-100471859","NCT05424354","Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing","Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds","Inclusion Criteria:\n\n* Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.\n* Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old\n* Wounds must be partial thickness, involving up to 20% of the total body surface area.\n* Burn injury should be less than 72 hours old\n* Willing and able to comply with protocol mandated scheduled study visits\u002Fclinical evaluations.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to TPD or its components\n\n  * Women who are pregnant, breast feeding, or plan to get pregnant during the study period.\n* Infected wounds\n* Presence of any full thickness (third degree) burns\n* Electrical burns\n* Heavily draining burns due to underlying chronic lymphedema or other conditions\n* Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.\n* History of poor wound healing and\u002For skin\u002Fimmune system condition\n\n  * Deemed by clinician not to be suitable\n* Unwilling or not able to provide consent or comply with protocol or required visits\n* Developmental disability\u002Fsignificant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol\n* Active alcohol or substance abuse","65 Years",{"count":57,"type":22},60,[59],"PHASE4","This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.",[62],"Wounds and Injuries",[64],"burn","2025-11-16",{"date":67,"type":39},"2025-11-19",{"date":69,"type":39},"2022-05-26",{"date":71,"type":22},"2026-09-30",{"name":45,"class":46},6,""]