[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-ulcers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-ulcers":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,93,123,149],{"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":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100623062","early-phase-1-efficacy-of-a-polyhexanide-biguanide-based-gel-in-the-prevention-of-biofilm-formation-in-pressure-ulcers-100623062",false,"NCT07391748","Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers","EGELPUPP","Inclusion Criteria:\n\n* Bedridden patients, patients with bed-to-chair mobility, or those in a wheelchair.\n* Presenting one or more category II-III pressure ulcers.\n* Aged over 65 years.\n* Patients with laboratory results within normal metabolic values (HbA1c \\\u003C 7%).\n* Patients who, in item 6 \"infection\u002Fsuspected biofilm\" of the RESVECH 2.0 index, do not have tissue compatible with biofilm, hypergranulation, or purulent exudate, and never score more than 4 in the other items.\n* During follow-up, cases that develop signs and symptoms of local infection according to TILI and\u002For the RESVECH 2.0 index will be considered therapeutic failures, allowing for clinical rescue, but the patient will remain in the intention-to-treat (ITT) analysis.\n\nExclusion Criteria:\n\n* Patients who, despite the above, present a deteriorated health status that could influence the outcome, such as terminally ill patients, oncology patients, or those with inflammatory diseases.\n* Patients in a state of malnutrition according to the Mini Nutritional Assessment (MNA®) scale who are not receiving nutritional supplements, and\u002For at risk of malnutrition with nutritional deficits.\n* Patients with pressure ulcers in the perineal area and urinary incontinence (except those with a urinary catheter) and\u002For fecal incontinence.","ALL","65 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","INTRODUCTION: Pressure ulcers (PU) are one of the main challenges for nursing in our country. Wound bed preparation and the TIME algorithm provide essential tools for adequately treating these lesions. However, these wounds tend to become chronic due to the bacterial load in their bed. It is now known that bacteria can form complex and diverse structures, named as biofilm, which are difficult to diagnose and much more resistant to antimicrobial action.\n\nControlling these biofilms is crucial to create the optimal conditions for wound healing. Currently, it is believed that biofilms are present in 60-100% of chronic wounds. Therefore, more studies are needed to evaluate the efficacy of different antimicrobial agents on these structures.\n\nOBJECTIVE: To determine the efficacy of a gel containing polyhexanide and biguanide, alone or in combination with alginate with or without silver, in preventing biofilm in PU, in terms of healing at 4 weeks.\n\nMETHODOLOGY: Multicenter clinical trial with a 2x2 factorial design, conducted with patients from Alcoy with category II and III PUs that meet the inclusion and exclusion criteria. A sample of 140 participants is estimated, distributed into four groups of 35 patients. The interventions that will be carried out will be: application of Prontosan gel® and Aquacel Ag+®; Aquacel Ag+®; control group; Prontosan gel®. Data on wound evolution will be collected using RESVECH 2.0. Descriptive statistical analysis and hypothesis testing will be performed.",[26,27,28,29,30,31,32],"Pressure Ulcers","Pressure Ulcers Stage III","Pressure Ulcer Prevention","Pressure Ulcer ( Stage 2-3)","Biofilm Formation","Biofilm","Biofilm Removal",[34,35,36,37],"Pressure ulcers","biofilms","primary prevention","antimicrobial agents","NOT_YET_RECRUITING","2026-02-06",{"date":41,"type":42},"2026-02-10","ACTUAL",{"date":44,"type":20},"2026-01-30",{"date":46,"type":20},"2026-09-30",{"name":48,"class":49},"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100588305","study-of-miro3d-wound-matrix-for-healing-wounds-and-ulcers-in-outpatient-care-100588305","NCT06939673","Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care","A Clinical Study of Reprise Biomedical's Miro3D Wound Matrix in the Outpatient Management of Wounds and Ulcerations","Inclusion Criteria:\n\n1. Age 18 or older and able to provide informed consent.\n2. Has an open wound or ulceration, preferably with tunneling or undermining.\n3. If multiple wounds\u002Fulcerations are present, only one will be selected for Miro3D treatment.\n4. Other wounds must be ≥2 cm away from the study wound.\n5. Wound should be debrided with a clinical goal of healing, even if some infection remains.\n6. Previous infections must be adequately treated and controlled (per IDSA guidelines).\n7. Willing and able to comply with offloading and\u002For compression requirements.\n8. Must have a stable living environment for wound care adherence.\n9. Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.\n10. Provides consent for digital photo documentation.\n\nExclusion Criteria:\n\n1. Active, untreated osteomyelitis.\n2. Malignancy or vasculitis at the wound site.\n3. Undergoing chemotherapy.\n4. On dialysis.\n5. Use of investigational drugs or therapies within 30 days before screening.\n6. Conditions that significantly impair study adherence or known history of medical non-compliance.\n7. Known sensitivity to porcine materials.\n8. Third-degree burns.\n9. Worsening ischemia or gangrene at screening.\n10. Prior radiation to the study wound site.\n11. Exposed hardware, implants, or fixation devices in the study wound.\n12. Receiving palliative or comfort care.","18 Years",{"count":59,"type":20},20,[61],"NA","This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort.\n\nThe study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat.\n\nParticipants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life.\n\nThe main goals of the study are:\n\n1. To measure how much the wound size shrinks (known as percent area reduction or PAR).\n2. To evaluate how much healthy granulation tissue (new tissue) forms in the wound.\n3. To compare healing outcomes when Miro3D is used weekly versus every two weeks.\n4. To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing.\n\nEach participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.",[64,65,26,66,67,68],"Diabetic Foot Ulcers (DFUs)","Venous Leg Ulcers (VLUs)","Surgical Wound Dehiscence (SWD)","Chronic Wounds","Undermined and Tunneling Wounds",[70,71,72,73,74,75,76,77,78,79,80],"Miro3D Wound Matrix","Acellular Wound Matrix","Porcine-Derived Scaffold","Chronic Wound Healing","Diabetic Foot Ulcer Treatment","Pressure Ulcer Management","Surgical Wound Dehiscence Therapy","Venous Leg Ulcer Treatment","Tunneling and Undermining Wounds","Complex Wound Management","Reprise Biomedical","RECRUITING","2025-12-22",{"date":84,"type":42},"2025-12-24",{"date":86,"type":42},"2024-02-29",{"date":88,"type":20},"2025-12-31",{"name":90,"class":91},"Reprise Biomedical, Inc.","INDUSTRY",2,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":112,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":5},"100616968","multicenter-randomized-non-inferiority-study-to-compare-the-performance-and-safety-of-debrisoft-duo-with-debrisoft-pad-in-the-debridement-of-wounds-100616968","NCT07312513","Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient is legally capable\n* Patient has signed written informed consent\n* Presence of one of the following wounds\n\n  * Venous lower leg ulcer\n  * Arterial ulcer\n  * Diabetic ulcer\n  * Pressure ulcer\n  * Post-operative wound healing by secondary intention\n  * Traumatic wound\n  * Surgical wound\n  * Burn or scald (grade III: after surgical debridement)\n  * Epidermolysis Bullosa\n* Wound area \\>4cm2\n* The entire wound area can be displayed on one photo from a distance of 25-30 cm\n* Covered with at least 30% debris, necrosis, slough, fibrotic tissue\n\nExclusion Criteria:\n\n* Known allergy and\u002For hypersensitivity to Debrisoft® Duo or any of the product components\n* Pregnancy or breast feeding\n* Patient is illiterate\n* Participation in a interventional clinical trial within the last 14 days and during participation in this study\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and\u002F or interpretation of the study results\n* severe pain or hyperesthesia in the wound area\n* history of drug or alcohol abuse\n* chronic analgesic use (especially opioids) that could influence baseline pain perception\n* cognitive impairment, which may affect the ability to accurately self-report pain\n* Use of anaesthesia before the debridment procedure\n* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary",{"count":100,"type":20},104,[61],"The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.",[104,105,106,26,107,108,109,110,111],"Diabetic Ulcers","Arterial Ulcers","Venous Ulcers","Postoperative Wounds Healing by Secondary Intention","Burns and Scalds","Epidermolysis Bullosa (EB)","Traumatic Wounds","Surgical Wounds",[113,114],"Debridement","mechanical debridement","2025-12-17",{"date":88,"type":42},{"date":118,"type":42},"2025-05-09",{"date":120,"type":20},"2026-02",{"name":122,"class":91},"Lohmann & Rauscher",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100610154","phase-3-efficacy-of-carbonlife-amniotic-tissue-product-in-the-treatment-of-chronic-wounds-100610154","NCT07223892","Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds","A Prospective Controlled Trial Evaluating the Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds: A Stratified Analysis by Wound Etiology and Care Setting","Inclusion Criteria:\n\n* Facilities and centers with the capacity to follow strict treatment and care guidelines for patients.\n* Adults aged 18 years or older.\n* Presence of a chronic wound (defined as a wound that has not shown significant improvement in 4 weeks) of any of the following etiologies: Diabetic foot ulcers, Venous leg ulcers, Arterial ulcers, Pressure ulcers, Burns, Trauma, Surgical\n* Wound size greater than 1 cm²\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Presence of active osteomyelitis\n* Untreated malignancy in the wound area\n* Known allergy to components of ATPs\n* Pregnant or breastfeeding women\n* Patients receiving immunosuppressive therapy\n* Patients with a life expectancy of less than 12 weeks",{"count":131,"type":20},600,[133],"PHASE3","Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs. These wounds are characterized by delayed healing and are often associated with complex etiologies and prolonged treatment courses. This study aims to evaluate the clinical efficacy and cost-effectiveness of Carbonlife amniotic tissue products (ATPs) compared to standard wound care in the management of chronic wounds. A prospective, controlled clinical trial will be conducted across diverse care settings and patient populations with varying wound etiologies. Participants will be stratified by wound type and treatment environment to enable subgroup analyses. The primary endpoint will assess wound healing outcomes, while secondary endpoints will include quality-of-life measures and healthcare resource utilization. The study is designed to generate high-quality evidence regarding the therapeutic value of ATPs in chronic wound management. Stratified analyses will provide insights into the differential effectiveness of ATPs across clinical contexts. Findings are anticipated to have implications for clinical practice guidelines and healthcare policy, with the goal of improving patient outcomes and optimizing resource allocation in wound care.",[67,65,64,105,26,136,137,111],"Burn Wounds","Trauma Wounds",[139],"chronic wounds","2025-11-04",{"date":142,"type":42},"2025-11-06",{"date":144,"type":20},"2026-01-01",{"date":146,"type":20},"2028-03",{"name":148,"class":91},"Bardia Anvar",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":168,"locationsCount":170},"100572188","dermacyte-liquid-for-treatment-of-cutaneous-ulcers-and-wounds-100572188","NCT06730022","Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds","Inclusion Criteria:\n\n* Must be 18 years of age or older\n* Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator\n\nExclusion Criteria:\n\n* Must not be pregnant or lactating\n* Must not have known malignancies\n* Must not be less than 18 years of age","EXPANDED_ACCESS","The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.",[158,159,160,161,26,162,163],"Cutaneous Ulcer","Diabetic Ulcer","Surgical Wound Dehiscence","Burns - Multiple","Mixed Ulcer","Ischemic Ulcer","AVAILABLE","2025-02-21",{"date":167,"type":42},"2025-02-25",{"name":169,"class":91},"Merakris Therapeutics",1]