[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-ulcer-pu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-ulcer-pu":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,86,112,141,168,200,262],{"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":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":49},"100634554","paw-hydrogel-for-chronic-wound-healing-100634554","NCT07541196","PAW-Hydrogel for Chronic Wound Healing","Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer) with duration \\> 3 months.\n* Wound surface area between 2 cm² and 20 cm².\n* For diabetic patients: HbA1c \\\u003C 9% (stable metabolic control).\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Clinical or radiological evidence of osteomyelitis (Wagner grade \\> 3).\n* Severe arterial insufficiency (ankle-brachial index \\\u003C 0.5).\n* Use of systemic corticosteroids or immunosuppressants.\n* Pregnancy or lactation.\n* Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).\n* Active malignancy or undergoing chemotherapy\u002Fradiotherapy.\n* Participation in another interventional clinical trial within 30 days prior to screening.",{"count":58,"type":20},50,[60],"NA","The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are:\n\n* Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care?\n* Does PAW-hydrogel reduce bacterial load in the wound bed?\n* Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)?\n\nParticipants will be randomly assigned to one of two groups:\n\n* Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week.\n* Control group: Standard advanced wound care (cleaning, debridement, conventional dressings).\n\nWound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.",[63,27,64,65,66,67],"Diabetic Foot Ulcer (DFU)","Wound Dehiscence","Venous Leg Ulcer","Arterial Ulcer","Chronic Wound",[69,70,71,72,73,74,75],"Plasma-Activated Water","PAW","Hydrogel","Chronic Wounds","Diabetic Foot","Wound Healing","RONS","2026-04-14",{"date":78,"type":41},"2026-04-21",{"date":80,"type":20},"2026-04-20",{"date":82,"type":20},"2027-07-30",{"name":84,"class":85},"Benjamín Gonzalo Rodríguez Méndez","OTHER",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":35,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100616613","the-effect-of-photobiomodulation-on-pressure-ulcers-100616613","NCT07307885","The Effect of Photobiomodulation on Pressure Ulcers","The Effect of Photobiomodulation on Pressure Ulcers: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with Stage II pressure ulcers\n* Patients without any skin disease\n* Patients with albumin, platelet, and blood glucose levels within normal ranges\n* Patients who will stay in the intensive care unit for 14 days or longer\n* Patients with a BMI of 35 or below\n* Patients with vital signs within normal limits\n* Patients with an oxygen saturation level of 90% or above\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the study\n* Patients with severe nutritional problems and those who are cachectic\n* Patients with severe edema (+4 or above)\n* Patients with diabetes mellitus\n* Patients who show photosensitivity in the light sensitivity test\n* Patients with metastatic tumors, high fever, thromboangiitis obliterans, vascular insufficiency, active tuberculosis, acute soft tissue infection, pregnancy, bleeding tendency, skin sensory disorders, or skin allergies\n* Patients with acute injuries within the past 72 hours\n* Patients with a pacemaker, defibrillator, or other electronic implants\n* Patients taking medications known to cause photosensitivity",true,{"count":95,"type":20},46,[60],"Photobiomodulation Group (Intervention Group):\n\nBefore the intervention, the patient's skin sensitivity to light will be tested by applying light for 3 minutes to one-fourth of the forearm skin. If redness occurs and persists for more than 2 hours, this indicates photosensitivity, and the intervention will not be performed.\n\nThe Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, vital signs will be measured, and then the intervention will begin. After routine wound care\u002Fcleaning procedures in the intensive care unit, without applying any medication, cream, or lotion to the wound area, red light (660 nm wavelength) will be applied to the wound area for 5 minutes at a distance of 55 cm during the first 3 days, and for 10 minutes at the same distance on the following days. This application will continue once daily for 14 days. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14 (Baracho et al., 2021; Viecelli et al., 2024; Lima et al., 2020).\n\nControl Group:\n\nThe Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, and vital signs will be measured. No intervention will be performed other than the routine wound care procedure carried out in the intensive care unit. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14, in the same manner as in the intervention group.",[27],[100,35,101],"photobiomodulation","wound care","NOT_YET_RECRUITING","2026-03-06",{"date":105,"type":41},"2026-03-09",{"date":107,"type":20},"2026-05-01",{"date":109,"type":20},"2027-05-20",{"name":111,"class":85},"Ankara Medipol University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100628052","using-music-during-wound-care-among-seniors-with-pressure-injuries-100628052","NCT07456618","Using Music During Wound Care Among Seniors With Pressure Injuries","Investigating the Use of Music During Wound Care","Inclusion Criteria:\n\n* 60 years or older\n* Has a stage II, III, or IV pressure injury\n\nExclusion Criteria:\n\n* Designated as end of life and\u002For has a Kennedy terminal pressure injury\n* Has an unstageable pressure injury\n* The pressure injury has necrotic tissue or necrotic bone present\n* The pressure injury is infected\n* The pressure injury is caused by a medical device in that area\n* Severe to profound hearing loss that is not corrected by a hearing aid or other assistive hearing device.","60 Years",{"count":58,"type":20},[60],"Pressure injuries (also known as pressure wounds or bed sores) are increasingly common among older adults living in care homes. These wounds often require regular dressing changes, which can be uncomfortable for some.\n\nThe researchers believe that listening to music during wound care may have an effect on pain, wound healing, and the overall wound care experience, compared with wound care without music.\n\nThe goal of this clinical study is to test this idea by examining whether listening to music before and during wound care is linked to differences in pain, wound healing, and the overall wound care experience in older adults with pressure injuries.\n\nThe main questions this study aims to answer are:\n\nDoes listening to music before and during pressure injury care affect pain during wound care? Does listening to music before and during pressure injury care affect how pressure injuries heal over time? Does listening to music affect the overall experience of pressure injury care? Researchers will compare wound care with music to wound care without music to better understand whether music makes a difference.\n\nThe study will take place in eleven long-term care homes in Ontario. Participants will be residents aged 60 years and older who have a stage II, III, or IV pressure injury and who are already receiving regular wound care as part of their usual care. This study will not include residents who have infected or necrotic wounds, or who are at the end of life.\n\nParticipants will continue to receive the same wound care they would normally receive. Some homes will include music during wound care, and some homes will not.\n\nParticipants in homes using music will:\n\nListen to a playlist of music they personally enjoy for about 15 minutes before wound care begins Continue listening to the music during the wound care procedure Be able to change the volume or stop the music at any time Participants in homes not using music will receive the same standard pressure injury care without music.\n\nInformation for the study will come from clinical records that nurses already complete during routine wound care, such as notes about pain and wound healing. Staff involved in playing the music will also complete a short questionnaire about their observations of the wound care experience. Photos of wounds that are already taken as part of usual care may be reviewed to look at healing over time.\n\nParticipants may take part in the study for up to six months or until their wound has healed. Taking part is voluntary, and participants or their decision-makers can choose to stop at any time. The study does not change the medical care participants receive.",[124,125,27],"Pressure Injuries","Pressure Injury",[35,125,127,128,129,130,131],"Music","Wound Care","Long-Term Care","Aged","Quality of Life","2026-03-03",{"date":103,"type":41},{"date":135,"type":20},"2026-04-01",{"date":137,"type":20},"2027-06-01",{"name":139,"class":85},"McMaster University",11,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100621787","evaluation-of-the-safety-and-efficacy-of-dehydrated-human-placenta-tissue-dhpt-for-wound-healing-100621787","NCT07375160","Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","RETRO-PLAST","Inclusion Criteria:\n\n* 18 years of age or older.\n* Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT).\n* Wound present for greater than or equal to 30 days prior to treatment with dHPT.\n* Wound is not infected.\n* Wound surface area is greater than 1cm2 at initial assessment.\n* Clinical documentation of wound treatment.\n\nExclusion Criteria:\n\n* AmchoPlast dHPT product was not applied to wound.\n* HbA1C \\>12%.\n* Presence of active osteomyelitis.\n* Concurrent treatment for malignant disease.\n* Use of other advanced biologics during treatment period.",{"count":150,"type":20},300,"OBSERVATIONAL","The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.",[63,154,27],"Venous Leg Ulcer (VLU)",[67,156,157,158,159],"Leg Wound","Amniotic","Allograft","Placenta","2026-02-27",{"date":132,"type":41},{"date":163,"type":20},"2026-04",{"date":165,"type":20},"2026-12",{"name":167,"class":48},"Cellution Biologics",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":93,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100615991","evidence-based-nursing-to-reduce-adverse-events-regarding-ventilator-associated-pneumonia-pressure-injuries-and-central-line-bloodstream-infection-in-intensive-care-unit-in-bangladesh-100615991","NCT07299799","Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh","Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit: A Quasi-experimental Study in Bangladesh","EBP in Nursing","Trial 1 \\& 2-\n\nInclusion Criteria:\n\nNurse\n\n* who is a registered nurse in Bangladesh.\n* who agrees to participate in this study and the EBP training.\n* who will stay at the ICU for 6 months. Patient\n* Irrespective of age and sex, participants must be at least 18 years old\n* Legal guardian of a patient consent to participation in the study\n\nExclusion Criteria:\n\nNurse\n\n* Who will not directly involve patient care in ICU. Patient\n* No exclusion criteria",{"count":177,"type":20},272,[60],"Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as Ventilator Associated Pneumonia (VAP), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU), and Central Line-Associated Bloodstream Infection (CLABSI). VAP, PU, and MDRPU are significant indicators of the quality of care, while CLABSI is a critical marker of healthcare quality in ICUs, as it is largely preventable through strict adherence to infection control protocols.\n\nVAP is a lung infection that occurs in patients receiving mechanical ventilation for more than 48 hours. A PU is defined as localized damage to the skin or underlying tissue caused solely by pressure, while MDRPUs may also result from friction or pressure from medical devices or other objects. CLABSI is a severe infection caused by improperly inserted or maintained central venous catheters, which underscores the need for stringent catheter management protocols.",[181,182,27,183],"Ventilator Acquired Pneumonia","Central Line Associated Blood Stream Infections (CLABSI)","Medical Device Related Pressure Ulcer (MDRPU)",[185,186,187,35,188,189],"evidence based practice","Nurses competency","Ventilator Associated Pneumonia","Central Line Bloodstream Infection","Medical Device Related Pressure Ulcer","2026-02-10",{"date":192,"type":41},"2026-02-11",{"date":194,"type":20},"2026-02-15",{"date":196,"type":20},"2026-05-30",{"name":198,"class":85},"Hiroshima University",2,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":208,"targetDuration":210,"studyType":151,"phases":4,"briefSummary":211,"conditions":212,"keywords":227,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"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":209,"type":20},300000,"5 Years","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.",[73,35,213,214,26,215,216,217,218,219,220,221,222,27,223,125,224,225,226,30],"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)","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds",[228,229,230,231,232,233,234,65,35,125,66,235,219,236,237,238,239,240,241,242,243,244,245,246,247,248,74,249,250,251,252],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Diabetic Foot 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","Amputation","Electronic Health Record (EHR)","Debridement","Standard of Care","2025-07-10",{"date":255,"type":41},"2025-07-16",{"date":257,"type":41},"2005-01-01",{"date":259,"type":20},"2030-01",{"name":261,"class":85},"U.S. Wound Registry",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":4},"100590179","evaluation-of-cold-plasma-in-chronic-wound-healing-100590179","NCT06964048","Evaluation of Cold Plasma in Chronic Wound Healing","Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.","PLASANAGENESIS","Inclusion Criteria:\n\n* Adult patient, age ≥ 18 years,\n* Patients affiliated with a social security system or benefiting from such a system,\n* Patients able and willing to provide written informed consent,\n* Patients able and willing to attend regular follow-up visits during up to 20 weeks, and comply with study procedures,\n* Patients whose home healthcare professional is willing to follow the clinical investigation protocol,\n* Patient with gas conformed stockage area (ventilated or at least 7m²)\n* Patients without infection, or with a local controlled infection,\n* Patients with VLU:\n\n  * Patients with wound anteriority between 1 to 12 months\n  * Patients with VLU or mixed ulcer of predominantly venous origin (measured ankle brachial index (ABI) such as 1.3 ≥ ABI ≥ 0.8)\n  * Patients with VLU between 4 to 30 cm² in surface area,\n  * Patients with only one VLU,\n  * Patients who have not shown wound healing improvement after wearing compression system for at least two weeks\n* Patients with DFU:\n\n  * Patients with wound duration between 1 to 12 months\n  * Patients with DFU and with measured ABI ≥ 0.8 or Toe Brachial Index (TBI) ≥ 0.7\n  * Patients with DFU between 1 to 30 cm² in surface area,\n  * Patients with only one DFU, not between toes,\n  * Patients who have not shown wound healing improvement after wearing an offloading system for at least two weeks,\n* Patient with PU:\n\n  * Patient with wound duration between 1 to 12 months\n  * Patient with PU stage 2 or 3 NPUAP grade,\n  * Patient with PU and with ABPI ≥ 0.8 and ≤ 1.3 and\u002For Toe Brachial Index (TBI) ≥ 0.7 if PU on the foot\n  * Patient with PU between 4 to 30 cm² in surface area,\n  * Patient with only one PU\n  * Patient able and willing to wear off loading system or to be install on pressure relieving system et changing position regularly,\n\nExclusion Criteria:\n\n* Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.\n* Patients with an active Charcot's neuro-arthropathy as determined by clinical and\u002For radiographic examination,\n* Patients with critical limb ischemia or severe PAD (ankle pressure \\\u003C 50 mmHg or Toe pressure \\\u003C 30 mmHg).\n* Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.\n* Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,\n* Patients with non-controlled systemic infection by a suitable antibiotic,\n* Patients with suspicion of severe malnutrition,\n* Pregnancy or breastfeeding woman, or susceptible to be pregnant,\n* Patients with known allergy or hypersensitivity to components of the cold plasma device or standard wound care products,\n* Patients included in another study,\n* Patients under guardianship or protection of vulnerable adult.\n* Patients with implantable electro-medical devices.\n* Patients with a history of hypersensitivity or known allergy to medical argon or any component of the device.\n* Infected wounds requiring urgent medical or surgical treatment before the application of any device.",{"count":271,"type":20},66,[60],"The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone?\n\nResearchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing.\n\nParticipants will:\n\n* Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization.\n* Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires.\n* Be followed up at home by nurses for wound care, treatment administration and clinical assessment too.\n* Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.",[72,154,63,27],[276,65,277,234,278,35,279,280,281,282,283,284,285],"Chronic wounds","VLU","DFU","PU","Cold Atmospheric Plasma","CAP","Plasma","Cold Plasma","Healing","Wound Closure","2025-04-30",{"date":288,"type":41},"2025-05-09",{"date":290,"type":20},"2025-06",{"date":292,"type":20},"2026-05",{"name":294,"class":48},"Plasana Medical"]