[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634554":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":57,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":87,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"National Institute of Nuclear Research - Mexico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PAW-Hydrogel","EXPERIMENTAL","Participants randomized to this arm will receive topical application of the investigational product: a Carbopol® 940 hydrogel (1% w\u002Fv) neutralized to pH 5.5 and functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS). At each wound care session (2-3 times per week), the wound bed is first cleaned with sterile saline. A uniform layer of PAW-hydrogel is then applied to cover the entire wound surface, followed by a sterile secondary occlusive dressing. The hydrogel remains in place until the next scheduled dressing change. Treatment continues for up to 12 weeks or until complete wound closure, whichever occurs first.",[13],"Device: PAW-Functionalized Carbopol® 940 Hydrogel",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Advanced Wound Care","ACTIVE_COMPARATOR","Participants randomized to this arm will receive the institution's current standard advanced wound care protocol for chronic wounds, as routinely practiced at the Centro Médico ISSEMYM Wound Clinic. At each wound care session (2-3 times per week, consistent with the experimental arm), the wound bed is first cleaned with sterile saline, followed by mechanical debridement of devitalized tissue if clinically indicated by the treating clinician. Subsequently, a conventional advanced dressing is selected according to wound characteristics (exudate level, presence of infection, and tissue type) and applied to cover the wound bed, followed by a sterile secondary dressing. The dressing is changed at each scheduled visit. All participants also receive standard concomitant care as per institutional protocols.",[19],"Other: Standard Advanced Wound Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PAW-Functionalized Carbopol® 940 Hydrogel","Topical application of a 1% w\u002Fv Carbopol® 940 hydrogel neutralized to pH 5.5, functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS, including H₂O₂, O₃, NO₂-, NO₃-). A uniform layer (3-5 mm thick) is applied to the entire wound bed after saline cleaning, covered with a sterile secondary dressing. Frequency: 2-3 times per week depending on exudate level.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Conventional advanced wound care following institutional protocol, including wound cleaning with saline, mechanical debridement, and application of standard dressings (e.g., alginate, foam, or silver dressings as clinically indicated). No PAW-hydrogel is used.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Régulo López-Callejas, PhD","CONTACT","+52 5553297200","12239","regulo.lopez@inin.gob.mx",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Plasma Physics Laboratory, National Institute of Nuclear Research","RECRUITING","Ocoyoacac","State of Mexico","52750","Mexico","MX",{"type":47,"coordinates":48},"Point",[49,50],-99.45787,19.27127,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":55,"email":56},"Diego Medina-Castro, PhD","12230","diego.medina@inin.gob.mx",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Benjamín Gonzalo Rodríguez Méndez","Principal Investigator",[62],{"name":63,"class":6},"Centro Medico Issemym","100634554","paw-hydrogel-for-chronic-wound-healing-100634554",false,"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.","ALL","18 Years",{"count":74,"type":75},50,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81,82,83,84,85,86],"Diabetic Foot Ulcer (DFU)","Pressure Ulcer (PU)","Wound Dehiscence","Venous Leg Ulcer","Arterial Ulcer","Chronic Wound",[88,89,90,91,92,93,94],"Plasma-Activated Water","PAW","Hydrogel","Chronic Wounds","Diabetic Foot","Wound Healing","RONS","2026-04-14",{"date":97,"type":98},"2026-04-21","ACTUAL",{"date":100,"type":75},"2026-04-20",{"date":102,"type":75},"2027-07-30",{"name":59,"class":6},1]