[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477386":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":336,"collaborators":338,"id":342,"slug":343,"hasResults":344,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":35,"eligibilityCriteria":348,"healthyVolunteers":349,"sex":350,"minAge":351,"maxAge":352,"enrollmentInfo":353,"targetDuration":35,"studyType":356,"phases":357,"briefSummary":359,"conditions":360,"keywords":364,"overallStatus":43,"whyStopped":35,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":377},{"fullName":5,"class":6},"ULURU Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care Dressing for Pressure Injury","ACTIVE_COMPARATOR","Standard wound dressings recommended by the National Pressure Injury Advisory Panel (NPIAP), according to the wound stage, will be utilized to treat pressure injuries. These include hydrocolloid, hydrogel, polymeric membranes, foam, collagen dressings, and negative pressure wound therapy. Dressings will be changed according to wound conditions, and type of dressing selected.",[13],"Device: Altrazeal® Transforming Powder Dressing",{"label":15,"type":10,"description":16,"interventionNames":17},"Altrazeal® Transforming Powder Dressing","Altrazeal® Transforming Powder Dressing will be applied during the Baseline visit. It should be left in place for up to 30 days, and topped off (additional powder applied if needed) at each subsequent visit. Secondary dressing, including a contact layer over the Altrazeal® and a secondary dressing (like gauze or foam) may be applied over the contact layer.",[13],[19],{"type":20,"name":15,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Pressure injury wounds will be evaluated at each study visit (cleaned, photographed, measured) and a dressing will be applied according to the study arm",[15,9],[24],"Standard of Care wound dressings (such as foam, hydrocolloid, collagen, etc)",[26],{"name":27,"affiliation":28,"role":29},"Saxe Johathan, MD","Altrazeal Life Sciences Inc","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Kerry Wallace","CONTACT","513 702 7536",null,"kwallace@altrazeal.com",{"name":38,"role":33,"phone":35,"phoneExt":35,"email":39},"Susan St. John, MSN","sstjohn@altrazeal.com",[41,67,84,102,113,132,148,170,202,219,237,259,285,313],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"San Diego VA","RECRUITING","San Diego","California","92161","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-117.16472,32.71571,{"lat":53,"lon":52},[56,60,63,64],{"name":57,"role":33,"phone":58,"phoneExt":35,"email":59},"Henry York, MD","858-552-8585","Henry.York@va.gov",{"name":61,"role":33,"phone":58,"phoneExt":35,"email":62},"Emily Sears","esears@vmrf.org",{"name":57,"role":29,"phone":35,"phoneExt":35,"email":35},{"name":65,"role":66,"phone":35,"phoneExt":35,"email":35},"Melissa Brito, NP","SUB_INVESTIGATOR",{"facility":68,"status":43,"city":69,"state":70,"zip":71,"country":47,"countryCode":48,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Medstar Georgetown University Hospital","Washington D.C.","District of Columbia","20007",{"type":50,"coordinates":73},[74,75],-77.03637,38.89511,{"lat":75,"lon":74},[78,82],{"name":79,"role":33,"phone":80,"phoneExt":35,"email":81},"Deanna Curbeam","202 444 8751","Deanna.Curbeam@medstar.net",{"name":83,"role":29,"phone":35,"phoneExt":35,"email":35},"Kenneth Fan, MD",{"facility":85,"status":43,"city":69,"state":70,"zip":86,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"MedStar National Rehabilitation Hospital","20010",{"type":50,"coordinates":88},[74,75],{"lat":75,"lon":74},[91,95,98,100],{"name":92,"role":33,"phone":93,"phoneExt":35,"email":94},"Suzanne L Groah, MD","(202) 877-1000","Suzanne.L.Groah@medstar.net",{"name":96,"role":33,"phone":93,"phoneExt":35,"email":97},"Ana Valeria Aguirreguemez, MD","anavaleria.aguirreguemez@medstar.net",{"name":99,"role":29,"phone":35,"phoneExt":35,"email":35},"Suzanne Groah, MD",{"name":101,"role":66,"phone":35,"phoneExt":35,"email":35},"Erika Gosai",{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":47,"countryCode":48,"cosmosGeoPoint":108,"geoPoint":112,"contacts":35},"Northwestern Medicine","ACTIVE_NOT_RECRUITING","Chicago","Illinois","60611",{"type":50,"coordinates":109},[110,111],-87.65005,41.85003,{"lat":111,"lon":110},{"facility":114,"status":43,"city":115,"state":116,"zip":117,"country":47,"countryCode":48,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Medstar Franklin Square Medical Center","Baltimore","Maryland","21237",{"type":50,"coordinates":119},[120,121],-76.61219,39.29038,{"lat":121,"lon":120},[124,128,131],{"name":125,"role":33,"phone":126,"phoneExt":35,"email":127},"Paul Carroll, DPM","(443) 777-7000","paul.j.carroll@medstar.net",{"name":129,"role":33,"phone":126,"phoneExt":35,"email":130},"Sariat Ibrahim","Sariat.Ibrahim@medstar.net",{"name":125,"role":29,"phone":35,"phoneExt":35,"email":35},{"facility":133,"status":43,"city":115,"state":116,"zip":134,"country":47,"countryCode":48,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Medstar Good Samaritan Hospital","21239",{"type":50,"coordinates":136},[120,121],{"lat":121,"lon":120},[139,143,146],{"name":140,"role":33,"phone":141,"phoneExt":35,"email":142},"Lumanti Manandhar","(443) 444-8000","lumanti.Manandhar@medstar.net",{"name":144,"role":33,"phone":141,"phoneExt":35,"email":145},"Mia Hamm","Mia.A.Hamm@Medstar.net",{"name":147,"role":29,"phone":35,"phoneExt":35,"email":35},"David Martin, MD",{"facility":149,"status":43,"city":150,"state":151,"zip":152,"country":47,"countryCode":48,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Rutgers New Jersey Medical School, Ambulatory Care Center-Wound Care Clinic","Newark","New Jersey","07103",{"type":50,"coordinates":154},[155,156],-74.17237,40.73566,{"lat":156,"lon":155},[159,163,166,168],{"name":160,"role":33,"phone":161,"phoneExt":35,"email":162},"Mark Granick, MD","973-972-1129","mgranickmd@njms.rutgers.edu",{"name":164,"role":33,"phone":35,"phoneExt":35,"email":165},"Saharsh Patel","ssp186@gsbs.rutgers.edu",{"name":167,"role":66,"phone":35,"phoneExt":35,"email":35},"Alex Wong, MD",{"name":169,"role":66,"phone":35,"phoneExt":35,"email":35},"Edward Lee, MD, MS",{"facility":171,"status":43,"city":172,"state":173,"zip":174,"country":47,"countryCode":48,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Northwell Health System\u002FZucker School of Medicine","Lake Success","New York","11042",{"type":50,"coordinates":176},[177,178],-73.71763,40.77066,{"lat":178,"lon":177},[181,185,188,190,192,194,196,198,200],{"name":182,"role":33,"phone":183,"phoneExt":35,"email":184},"Sally Kaplan, RN","516-233-3781","skaplan2@northwell.edu",{"name":186,"role":33,"phone":183,"phoneExt":35,"email":187},"Farisha Baksh","fbaksh@northwell.edu",{"name":189,"role":29,"phone":35,"phoneExt":35,"email":35},"Alisha Oropallo, MD",{"name":191,"role":66,"phone":35,"phoneExt":35,"email":35},"Christina Del Pin, MD",{"name":193,"role":66,"phone":35,"phoneExt":35,"email":35},"Marisa Ranire-Maguire, MD",{"name":195,"role":66,"phone":35,"phoneExt":35,"email":35},"Russell Caprioli, DPM",{"name":197,"role":66,"phone":35,"phoneExt":35,"email":35},"John Haight, DPM",{"name":199,"role":66,"phone":35,"phoneExt":35,"email":35},"Michael Pliskin, DPM",{"name":201,"role":66,"phone":35,"phoneExt":35,"email":35},"Gawlik Scott, DPM",{"facility":203,"status":43,"city":204,"state":173,"zip":205,"country":47,"countryCode":48,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"NYU Langone Hospital-Long Island","Mineola","11501",{"type":50,"coordinates":207},[208,209],-73.64068,40.74927,{"lat":209,"lon":208},[212,216],{"name":213,"role":33,"phone":214,"phoneExt":35,"email":215},"Scott Gorenstein, MD","516-663-8498","Scott.gorenstein@nyulangone.org",{"name":217,"role":33,"phone":214,"phoneExt":35,"email":218},"Monica Benitez","Monica.Benitez@nyulangone.org",{"facility":220,"status":43,"city":221,"state":173,"zip":222,"country":47,"countryCode":48,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"James J. Peters VA Medical Center","The Bronx","10468",{"type":50,"coordinates":224},[225,226],-73.86641,40.84985,{"lat":226,"lon":225},[229,234],{"name":230,"role":33,"phone":231,"phoneExt":232,"email":233},"Galea Marinella, MD","718-584-9000","5431","Marinella.Galea@va.gov",{"name":235,"role":33,"phone":231,"phoneExt":232,"email":236},"Katherine Bolanos Roldan, RN","Katherine.BolanosRoldan@va.gov",{"facility":238,"status":43,"city":239,"state":173,"zip":240,"country":47,"countryCode":48,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Westchester Medical Center, 100 Woods, Road, Taylor Care Pavillion","Valhalla","10595",{"type":50,"coordinates":242},[243,244],-73.77513,41.07482,{"lat":244,"lon":243},[247,251,254,256,258],{"name":248,"role":33,"phone":249,"phoneExt":35,"email":250},"Carlo Gwardschaladse, PA","914-493-3047","Carlo.Gwardschaladse@wmchelath.org",{"name":252,"role":33,"phone":35,"phoneExt":35,"email":253},"Falyn Katzman, MPH","Falyn.Katzman@wmchealth.org",{"name":255,"role":29,"phone":35,"phoneExt":35,"email":35},"Helen Perakis, MD",{"name":257,"role":66,"phone":35,"phoneExt":35,"email":35},"Michelle Bravo, MD",{"name":248,"role":66,"phone":35,"phoneExt":35,"email":35},{"facility":260,"status":43,"city":261,"state":262,"zip":263,"country":47,"countryCode":48,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"University of Pittsburgh Medical Center (UPMC) Presbyterian","Pittsburgh","Pennsylvania","15213",{"type":50,"coordinates":265},[266,267],-79.99589,40.44062,{"lat":267,"lon":266},[270,274,277,279,281,283],{"name":271,"role":33,"phone":272,"phoneExt":35,"email":273},"Cecilia Zamarripa, PhD, RN, CWON","412-647-7728","zamarripaca@upmc.edu",{"name":275,"role":33,"phone":272,"phoneExt":35,"email":276},"Bradley Good","goodb@upmc.edu",{"name":278,"role":29,"phone":35,"phoneExt":35,"email":35},"CeCe Zamarripa, PhD",{"name":280,"role":66,"phone":35,"phoneExt":35,"email":35},"Gayle Gordillo, MD",{"name":282,"role":66,"phone":35,"phoneExt":35,"email":35},"Amy Lynn Folk, RN, CWCN",{"name":284,"role":66,"phone":35,"phoneExt":35,"email":35},"Constance Greco, DNP",{"facility":286,"status":43,"city":287,"state":288,"zip":289,"country":47,"countryCode":48,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"VA North Texas Healthcare System","Dallas","Texas","75243",{"type":50,"coordinates":291},[292,293],-96.80667,32.78306,{"lat":293,"lon":292},[296,300,303,305,307,309,311],{"name":297,"role":33,"phone":298,"phoneExt":35,"email":299},"David Truong, DPM","214-857-2602","David.Truong1@va.gov",{"name":301,"role":33,"phone":298,"phoneExt":35,"email":302},"Morgan Williams","Morgan.Williams5@va.gov",{"name":304,"role":66,"phone":35,"phoneExt":35,"email":35},"James Blaine, DPM",{"name":306,"role":66,"phone":35,"phoneExt":35,"email":35},"Victoria Vo, DPM, MS",{"name":308,"role":66,"phone":35,"phoneExt":35,"email":35},"Roger Bedimo, MD",{"name":310,"role":66,"phone":35,"phoneExt":35,"email":35},"Anthony Ngoo, FNP",{"name":312,"role":66,"phone":35,"phoneExt":35,"email":35},"Tonyka James, DPM",{"facility":314,"status":43,"city":315,"state":288,"zip":316,"country":47,"countryCode":48,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Michael E. DeBakey Houston VAMC","Houston","77030",{"type":50,"coordinates":318},[319,320],-95.36327,29.76328,{"lat":320,"lon":319},[323,327,330,332,334],{"name":324,"role":33,"phone":325,"phoneExt":35,"email":326},"Aimee Garcia, MD","512-387-1876","Aimee.Garcia@va.gov",{"name":328,"role":33,"phone":325,"phoneExt":35,"email":329},"Felipe Salinas Martinez","Felipe.SalinasMartinez@va.gov",{"name":331,"role":66,"phone":35,"phoneExt":35,"email":35},"Delma Jara, MD",{"name":333,"role":66,"phone":35,"phoneExt":35,"email":35},"Ana Macias",{"name":335,"role":66,"phone":35,"phoneExt":35,"email":35},"Sarwat Jabeen, MD",{"type":337,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[339],{"name":340,"class":341},"United States Department of Defense","FED","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":354,"type":355},300,"ESTIMATED","INTERVENTIONAL",[358],"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.",[361,362,363],"Pressure Ulcers Stage II","Pressure Ulcers Stage III","Pressure Ulcer, Stage IV",[365,366,367],"Wound care","Quality of life","Pain","2025-11-17",{"date":370,"type":371},"2025-11-20","ACTUAL",{"date":373,"type":371},"2023-04-30",{"date":375,"type":355},"2026-12",{"name":5,"class":6},14]