[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-ulcer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-ulcer-stage-iv":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100537911","phase-2-a-randomized-controlled-phase-ii-trial-of-stimulan-vg-vs-standard-of-care-soc-for-the-treatment-of-osteomyelitis-associated-with-stage-iv-pressure-ulcers-100537911",false,"NCT06283979","A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","BLADE OPU2","In order to be eligible to participate in this study, subjects must meet all of the following criteria:\n\n1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage\u002Fprimary closure.\n2. Operative candidate for flap surgery or primary closure.\n3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.\n4. Adults ≥ 18 years in age at the time of treatment.\n5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.\n6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.\n\nSubjects who meet any of the following criteria will be excluded from participating in this study:\n\n1. Reasons contributing to pressure ulcer cannot be addressed.\n2. Severe immunological compromised patients as determined by the clinician.\n3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.\n4. Patients presenting with head pressure ulcers.\n5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety\u002Frecovery or ability to follow the trial procedures.\n6. Current smoker.\n7. Diabetic patient with Hba1C level above 9.\n8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).\n9. Concurrent involvement in a study of another investigational product.\n10. Pregnant or planning to become pregnant during study period.\n11. Flexion contractures where patient cannot passively get full extension.\n12. Uncontrolled muscle spasms.\n13. Unable to comply with bedrest restriction or offloading requirements\n14. Unable to provide consent.\n15. Fecal or urinary incontinence with contamination of the wound.\n16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \\*\n17. Investigator considers the participant to be clinically malnourished.\n18. Any conditions with known hypercalcemia (\\> 10.3 mg\u002Fdl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).\n19. Investigator believes trial participation may compromise safety of the participant or trial results.\n\n    * Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.",[27,28],"Pressure Ulcer, Stage IV","Osteomyelitis",[30,31,32,33],"between-group effect size","surgical debridement","ulcer bursectomy","systemic antibiotics","RECRUITING","2026-05-01",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":38},"2025-06-15",{"date":42,"type":21},"2026-12-01",{"name":44,"class":45},"Biocomposites Ltd","INDUSTRY",9,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"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":57,"type":21},300,[59],"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.",[62,63,27],"Pressure Ulcers Stage II","Pressure Ulcers Stage III",[65,66,67],"Wound care","Quality of life","Pain","2025-11-17",{"date":70,"type":38},"2025-11-20",{"date":72,"type":38},"2023-04-30",{"date":74,"type":21},"2026-12",{"name":76,"class":45},"ULURU Inc.",14]