[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-ulcer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,72,103],{"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":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":49},"100636365","study-of-tolerance-to-the-application-of-cold-plasma-in-the-treatment-of-chronic-wounds-100636365","NCT07564739","Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds","PLASMA-SAFE","Inclusion Criteria:\n\n1. Men or women.\n2. Aged 18 years or older.\n3. Chronic wound or ulceration.\n4. Wound measuring 5 to 100 cm² of arterial or venous origin.\n5. Evolution \\> 4 weeks.\n6. With less than 30% necrosis.\n7. Able to give informed written consent.\n8. Blood pregnancy test for women of childbearing age.\n\nExclusion Criteria:\n\n1. Tumor wounds\n2. Dialysis\n3. Patients requiring surgical revascularization\n4. Severe heart failure (NYHA III-IV) or acute myocardial infarction.\n5. Wounds or ulcers located less than 10 cm from the patient's airways and respiratory tract\n6. Severe renal failure defined as creatinine clearance \\\u003C20 mL\u002Fmin calculated according to the MDRD\n7. Patients with severe hepatic impairment (class C) according to the Child Pugh score\n8. Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormality.\n9. Active malignant tumor\n10. Patients who, in the investigator's opinion, are at significant risk of suicide\n11. Any pre-existing physical or mental condition that may interfere with the patient's ability to comply with the administration schedule and\u002For protocol assessments, or that may compromise the patient's safety.\n12. Persons covered by Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (including minors and protected adults)\n13. Protected person (under guardianship or curatorship)\n14. Person under judicial protection\n15. Persons deprived of their liberty\n16. Persons not affiliated with a social security system\n17. Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study.\n18. Patients participating in another clinical trial evaluating a treatment\n19. Allergy to the dressings used in the trial",{"count":58,"type":20},40,[60],"NA","Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Diagnosis is essentially clinical, and there are many causes, but 90% of leg ulcers, for example, are primarily vascular in origin. There are wounds of traumatic, post-operative, and vascular origin, as well as pressure sores. The main purpose of invasive tests is to objectively determine the cause (arterial damage) or to check for underlying osteitis. Chronic wounds are usually infected or colonized by bacteria from the skin and digestive flora. There is no indication for antibiotic therapy in the treatment of wounds. Nursing staff play an important role in therapeutic management, which must be carried out in harmony with other healthcare professionals, such as general practitioners and specialists. This management has two main goals: to accelerate the epidermalization of chronic wounds, or even their healing, and to limit local and general complications, the recurrence of which remains the most difficult to control. There are many types of healing dressings available, adapted to each type of ulceration: fibrinous, necrotic, superinfected, etc.\n\nNevertheless, innovative solutions can accelerate healing, thereby reducing hospital stays, disabilities associated with chronic wounds, and complications such as skin-related septicemia. Research efforts may focus on the use of growth factors, for example, for old or stubborn forms of the disease, despite proper medical treatment, or on any other innovative technique.\n\nThe properties of cold plasma appear to be suitable for the treatment of chronic wounds, as has been demonstrated in cell models, animal models, and with argon plasma in several countries around the world on an experimental basis in humans.\n\nThe GREMI in Orléans has acquired internationally recognized expertise in the technique of cold helium plasma. The combination of this applied research laboratory and the Infectious Diseases Department of the Orléans University Hospital has led to the development of relationships that have resulted in the proposal to conduct this study, based in its first phase on the evaluation of the medical device's tolerance.",[36,30],"2026-05-12",{"date":65,"type":41},"2026-05-15",{"date":63,"type":41},{"date":68,"type":20},"2027-09",{"name":70,"class":71},"Centre Hospitalier Régional d'Orléans","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":49},"100613185","evaluation-of-diaphragmatic-function-after-interscalene-block-with-liposomal-bupivacaine-100613185","NCT07263295","Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine","Evaluation of Diaphragmatic Function After Interscalene Brachial Plexus Block With Liposomal Bupivacaine: A Cohort Study","Inclusion Criteria:\n\n* Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block\n* Aged ≥ 18 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n\nExclusion Criteria:\n\n* Known allergy or intolerance to amide local anesthetics\n* Nerve injury in the upper limb on the surgical side\n* Coagulopathy\n* Used opioid medications continuously for more than 3 weeks before surgery\n* History of pulmonary disease and a pulse oxygen saturation (SpO₂) \\\u003C 95% (measured after 5 minutes of rest at room temperature without oxygen supplementation, using a transcutaneous pulse oximeter)\n* Refuse to participate or are deemed unsuitable for this trial by the researchers\n\nWithdrawal Criteria:\n\n* Patients voluntarily withdrew their informed consent\n* Surgery was canceled or the anesthesia method was changed due to surgical factors before interscalene brachial plexus block",{"count":80,"type":20},120,[60],"The study aims to evaluation the effects of Liposomal Bupivacaine on diaphragmatic function in patients undergoing upper limb surgery who receive Interscalene Brachial Plexus Block. A total of 120 eligible patients will be enrolled and divided into two groups: Group A will receive 20ml of 0.5% Hydrochloride Bupivacaine , while Group B will receive 10ml of 0.5% Hydrochloride Bupivacaine plus 10ml of Liposomal Bupivacaine. Assessments of diaphragmatic function, pulmonary function, and pain intensity will be performed before the block and at different time points after the block, with follow-up for adverse events. The study is scheduled to run from September 2025 to September 2026, with strict adherence to privacy protection and ethical guidelines.",[84,85,86,87,30,88],"Diaphragmatic Function","Metacarpal Fracture","Radius Fracture","Peripheral Nerve Neurolysis","Upper Extremity Ligament Injury",[90,91,92],"Interscalene brachial plexus block","Liposomal Bupivacaine","Hemidiaphragmatic paralysis","NOT_YET_RECRUITING","2025-11-30",{"date":96,"type":41},"2025-12-04",{"date":98,"type":20},"2025-12-05",{"date":100,"type":20},"2026-12-20",{"name":102,"class":71},"Zhejiang University",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":111,"targetDuration":113,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":133,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":49},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679","NCT02280733","A Real-World Registry of Chronic Wounds and Ulcers","A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them","WOUNDJOURNEY","Inclusion Criteria:\n\n* Presence of one or more chronic wounds or ulcers of any etiology\n* Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)\n* Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system\n* All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)\n* All sexes and gender identities\n* All wound types and severities, including multiple wounds per patient\n\nExclusion Criteria:\n\n-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)",{"count":112,"type":20},300000,"5 Years","OBSERVATIONAL","WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.",[117,35,118,119,26,120,121,122,123,124,125,126,127,27,128,129,130,131,132,30],"Diabetic Foot","Surgical Wound Dehiscence","Vasculitis","Leg Ulcer","Pyoderma","Peripheral Arterial Disease","Lymphedema","Surgical Complication","Venous Leg Ulcers (VLUs)","Calciphylaxis","Sickle Cell Ulcer","Diabetic Foot Ulcers (DFUs)","Pressure Injury","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds",[134,135,136,137,138,139,140,141,35,129,142,143,124,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Diabetic Foot Ulcer","Venous Leg Ulcer","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","Advanced Wound Care","Skin Substitutes","CAMPs","CTPs","Negative Pressure Wound Therapy","NPWT","Collagen Dressings","Compression Therapy","Hyperbaric Oxygen Therapy","Wound Debridement","Real-World Evidence","Comparative Effectiveness","Wound Healing","Amputation","Electronic Health Record (EHR)","Debridement","Standard of Care","2025-07-10",{"date":164,"type":41},"2025-07-16",{"date":166,"type":41},"2005-01-01",{"date":168,"type":20},"2030-01",{"name":170,"class":71},"U.S. Wound Registry"]