[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624170":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"i+Med S.Coop.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ZKARE®","EXPERIMENTAL","Participants assigned to this arm receive standard wound care plus topical application of the investigational gel ZKARE®, applied using the ZKAPI® applicator during each wound-care session.",[13],"Device: ZKARE®",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Wound Care","ACTIVE_COMPARATOR","Participants assigned to this arm receive standard wound management according to routine clinical practice, without the use of the investigational product.",[19],"Procedure: Standard Wound Care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","ZKARE® is applied topically after routine wound cleansing and debridement. Using the sterile ZKAPI® applicator, the gel is distributed to fully cover the wound bed, including irregular or cavitated areas. The treated wound is then covered with the appropriate secondary dressing following standard clinical practice. The application is repeated at each treatment session until complete closure or the end of the 12-week follow-up period. All sessions include RESVECH 2.0 scoring, standardized photographs, and safety assessments",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"PROCEDURE","Standard care includes wound cleansing, debridement when required, and selection of secondary dressings according to wound characteristics such as exudate level, infection status, depth, and perilesional skin condition. No investigational gel is applied. At each treatment visit and follow-up time point, standardized wound photographs, RESVECH 2.0 scoring, closure metrics, and safety assessments are recorded according to the same schedule as the investigational arm.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Josune Torrecilla","CONTACT","+34945561134","jtorrecilla@imasmed.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Araba University Hospital","RECRUITING","Vitoria-Gasteiz","Álava","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],-2.67268,42.84998,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Garbiñe Ruiz de Gordoa","+34 945 00 70 00","garbiñe.ruizdegordoacampo@osakidetza.eus",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[58],{"name":59,"class":60},"Bioaraba Health Research Institute","NETWORK","100624170","efficacy-and-safety-of-zkare-gel-and-its-accessory-zkapi-in-the-treatment-of-chronic-ulcers-100624170",false,"NCT07406152","Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.","Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers: a Prospective, Randomized, Controlled Clinical Investigation.","Inclusion Criteria:\n\n* Adult patients (≥18 years).\n* Presence of at least one chronic hard-to-heal ulcer, including any of the following etiologies: Grade II, III or IV pressure ulcers; neuropathic diabetic foot ulcers (grade I, II or III), Wagner Grade I-III or Texas 0, I, II, III \u002F Stage B; class C6\u002FC6r venous leg ulcers measured with CEAP scale ; neuro-ischaemic ulcers with adequate distal perfusion (ABI\u002FITB ≥ 0.7-0.89; mild PAD); mixed-etiology venous ulcers and any chronic lower-limb lesion with palpable distal pulses.\n* Ulcer size between 1 cm² and 100 cm².\n* Ability and willingness to comply with all study visits and procedures according to the clinical protocol.\n* Ability to understand and sign the informed consent, obtained before performing any protocol-specific procedures.\n\nExclusion Criteria:\n\n* Ulcers of etiologies not listed in the inclusion criteria.\n* Ischaemic, neoplastic or atypical ulcers.\n* Severe comorbidities judged to compromise safety or study compliance, including: severe malnutrition, palliative\u002Fterminal status, severe anemia, decompensated heart failure, chronic kidney disease stage III\u002FIV or in dialysis.\n* Ulcers with moderate-severe or severe infection per PEDIS-IDSA infection grading scale.\n* Known allergy or sensitivity to any component of the investigational product.\n* Any condition that, in the investigator's opinion, may compromise patient safety or adherence to the protocol.\n* Pregnancy or planned breastfeeding.","ALL","18 Years",{"count":71,"type":72},134,"ESTIMATED","INTERVENTIONAL",[75],"NA","This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic, hard-to-heal ulcers. The study includes 134 ulcers of different etiologies-pressure ulcers, neuropathic diabetic foot ulcers, and venous leg ulcers-meeting predefined selection criteria. Participants are randomized to receive either ZKARE® in addition to standard wound care or standard care alone.\n\nThe primary efficacy endpoint is the change in wound condition assessed through the RESVECH 2.0 scale, recorded at baseline and throughout treatment and follow-up visits. The primary safety endpoint is the incidence of serious adverse events (SAEs). Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, quality-of-life measures (DLQI), patient satisfaction, investigator global assessment, cost-effectiveness, and product usability. The study aims to generate evidence on the performance, safety, and clinical usefulness of ZKARE® for chronic wound management.",[78],"Chronic Ulcers",[80,81,82,83,84],"Pressure ulcers","Hyaluronic acid","Wound healing","Topical gel","venous leg ulcers","2026-02-17",{"date":87,"type":88},"2026-02-19","ACTUAL",{"date":90,"type":88},"2025-11-14",{"date":92,"type":72},"2026-07",{"name":5,"class":6},1]