[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-ulcer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,83,149,174,216],{"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":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100559376","phase-2-guselkumab-in-the-treatment-of-adults-with-pyoderma-gangrenosum-pg-100559376","NCT06563323","Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)","A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum","GEORGE","Inclusion Criteria:\n\n* Willingness to comply with study procedures\u002Frequirements\n* Capable of giving informed consent\n* Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.\n* Undergoing at least once a week standard of care wound care at home or at a wound care facility\n* Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg\u002Fday for at least two weeks prior to first drug administration.\n* Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be sure that female partner(s) are using birth control that works well or not have sex.\n* Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study for at least 12 weeks following the last dose of guselkumab.\n* Willingness to travel to study site for all study visits or living \\>30 miles from study site and willing\u002Fable to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.\n* Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies at week 16. Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.\n\nExclusion Criteria:\n\n* Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab\n* Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:\n\n  1. 12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;\n  2. 8 weeks for infliximab;\n  3. 6 weeks for adalimumab;\n  4. 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK\u002FTYK pathway and PD4 inhibitors;\n  5. 2 weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof).\n\nIf not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.\n\n* Intralesional corticosteroids within 4 weeks of screening.\n* Active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.\n* Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for irritable bowel disease (IBD) or rheumatoid arthritis), are allowed as combination therapy except for Methotrexate (MTX) and Leflunomide which are allowed individually but not in combination.\n* Concurrent skin disease that is deemed to interfere with assessment of ulcer.\n* Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known malignancy or has a history of malignancy within 5 years before screening, with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mm Hg.\n* Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.\n* Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate in the study (40 weeks) which in the opinion of the investigator would pose an unacceptable risk to the subject.\n* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.\n* Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: Neutrophil count \\\u003C1500 cells\u002FµL, Lymphocyte count \\\u003C500 cells\u002FµL, Platelet count \\\u003C100,000 cells\u002FµL, AST or ALT or alkaline phosphatase \\> 2 times the upper limit of normal, Hemoglobin \\\u003C10 g\u002FdL, Serum creatinine ≥1.5 mg\u002FdL (SI: ≤137 μmol\u002FL), White blood cells \\\u003C3500 cells\u002F µL\n* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.\n* Individuals who are pregnant, lactating or breastfeeding.\n* History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.\n* Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.\n* Have signs or symptoms suggestive of active Tuberculosis (TB) upon medical history and\u002For physical examination. An exception is made for participants who are currently receiving treatment or will initiate treatment for latent TB prior to first administration of study intervention. For participants with a history of treated latent TB there must be documentation of appropriate treatment prior to the first administration of study intervention.\n* Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates immunity to the disease and will not be exclusionary.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).\n* Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug administration for Bacillus Calmette-Guérin (BCG) vaccine.\n* Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate families (spouse, parent, child, or sibling).\n* Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.","99 Years",{"count":60,"type":20},17,[62],"PHASE2","A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)",[65,66,67,68,26],"Pyoderma Gangrenosum","Skin Diseases","Wound Heal","Pyoderma",[70,71],"Guselkumab","IL-23 Inhibitor","2026-03-04",{"date":74,"type":41},"2026-03-06",{"date":76,"type":41},"2025-02-01",{"date":78,"type":20},"2027-08-13",{"name":80,"class":81},"Oregon Health and Science University","OTHER",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":112,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"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":92,"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.",[97,35,98,99,26,100,68,101,102,103,104,105,106,27,107,108,109,110,111,30],"Diabetic Foot","Surgical Wound Dehiscence","Vasculitis","Leg Ulcer","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",[113,114,115,116,117,118,119,120,35,108,121,122,103,65,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"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","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":142,"type":41},"2025-07-16",{"date":144,"type":41},"2005-01-01",{"date":146,"type":20},"2030-01",{"name":148,"class":81},"U.S. Wound Registry",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":49},"100451409","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-skin-ulcer-100451409","NCT05158127","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Skin Ulcer","Inclusion Criteria:\n\n* Diagnosis of Skin Ulcer\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur",{"count":157,"type":20},20,[159],"PHASE1","This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Skin Ulcer",[26],[26,163],"stem cell treatment","NOT_YET_RECRUITING","2025-04-15",{"date":167,"type":41},"2025-04-17",{"date":169,"type":20},"2025-12",{"date":171,"type":20},"2028-12",{"name":173,"class":81},"The Foundation for Orthopaedics and Regenerative Medicine",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":186,"conditions":187,"keywords":202,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":49},"100567960","clinical-trial-assessing-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-in-nonhealing-dfus-and-vlus-100567960","NCT06674980","Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","C5CAMP","Inclusion Criteria for DFU:\n\n1. At least 18 years of age or older.\n2. Must have diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.\n4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.\n5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n6. Target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n7. Subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and \\\u003C= 1.3\n   2. TBI \\>= 0.6\n   3. TCOM \\>= 40 mmHg\n   4. PVR: biphasic\n8. If subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.\n10. Subject must consent to using the prescribed offloading method for the duration of the study.\n11. Subject must agree to attend weekly study visits.\n12. Subject must be willing and able to participate in the consent process.\n\nExclusion Criteria for DFU:\n\n1. Subject is known to have a life expectancy of \\\u003C 6 months.\n2. Subject's target ulcer is not secondary to diabetes.\n3. Target ulcer is infected or there is cellulitis in the surrounding skin.\n4. Target ulcer exposes tendon or bone.\n5. Evidence of osteomyelitis complicating the target ulcer.\n6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The 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).\n8. Subject is taking hydroxyurea.\n9. Subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the 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 X width is acceptable).\n13. The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.\n14. Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.\n16. Subject has end stage renal disease requiring dialysis.\n17. Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n19. Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.\n20. Subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria for VLU:\n\nPotential subjects are required to meet all the following criteria for enrollment in the study.\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n6. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n7. The potential subject must agree to attend the weekly study visits required by the protocol.\n8. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria for VLU:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n3. The target ulcer exposes tendon or bone.\n4. There is evidence of osteomyelitis complicating the target ulcer.\n5. 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).\n6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n8. The surface area of the 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 X width is acceptable).\n9. The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n10. Women who are pregnant or considering becoming pregnant within the next 6 months.\n11. The potential subject has end stage renal disease requiring dialysis.\n12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n14. 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.\n15. The subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n16. A subject has a wound with active or latent infection is excluded.\n17. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":183,"type":20},177,[185],"NA","The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.",[188,189,190,191,192,193,194,195,100,26,66,196,197,198,97,199,200,33,201],"Pathologic Processes","Diabetes Mellitus","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Disease","Diabetic Angiopathies","Vascular Diseases","Cardiovascular Diseases","Diabetes Complications","Diabetic Neuropathies","Foot Diseases","Foot Ulcer","Diabetes Mellitus, Type 2","Foot Ulcer Unhealed",[203,204,205,206,207],"Human Placental Membrane (HPM)","Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Cellular, Acellular, and Matrix-like Product (CAMP)","Cellular and\u002For Tissue-Based Product (CTP)","2024-12-20",{"date":210,"type":41},"2024-12-27",{"date":208,"type":41},{"date":213,"type":20},"2027-01-22",{"name":215,"class":48},"C5 Biomedical",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":16,"minAge":17,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":234,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100544500","ideal-skiin-cares-bundle-to-prevent-pressure-injury-100544500","NCT06369688","IDEAL SKIIN CARES Bundle to Prevent Pressure Injury","Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial","IdealSkinCares","Inclusion Criteria:\n\n* be adults aged 18 years or older;\n* have been hospitalized for a minimum of 48 hours;\n* be willing to participate.\n\nExclusion Criteria:\n\n* patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;\n* have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);\n* be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);\n* individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;\n* patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;\n* admitted to the hospital for \\>28 days;\n* those with prior experience of PIs or training in PIs care and prevention.",true,"90 Years",{"count":227,"type":20},1620,[185],"The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.",[35,108,231,29,232,233,26],"Bed Sore","Decubitus Sore","Decubitus Ulcer",[108,235,236,237,238],"Care Bundle","Hospital-acquired pressure injury","Randomized Clinical Trial","IDEAL SKIIN CARES","2024-04-15",{"date":241,"type":41},"2024-04-17",{"date":243,"type":20},"2025-10-01",{"date":245,"type":20},"2027-10-01",{"name":247,"class":81},"Baqiyatallah Medical Sciences University"]