[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452483":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":62,"collaborators":65,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Diabetic Foot Ulcer study",null,"405 clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited . Wound swab for culture obtained. Baseline digital imaging of target wound(s). SF-12 Health survey, Visual Analogue Pain scale, Cardiff wound impact questionnaires. Wound site evaluation including TcOM\u002FTBI\u002Fankle brachial index (ABI) will be completed for subjects with wounds below the knee, if not already completed per standard of care within the previous 12 months. Hemoglobin A1c point of care testing will be drawn for diabetic subjects who do not have an A1c available within 90 days prior to enrollment; 3mm biopsy tissue or debrided tissue will be collected. Ideally, two tissue samples will be obtained; the subject's medical records will be reviewed and followed for up to 16 weeks or until their wound has closed, whichever comes first. The research staff will also call the patient or care facility as needed to check for wound closure.",[13],{"name":14,"affiliation":5,"role":15},"Chandan K Sen, PhD","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Piya Das Ghatak, PhD, MS","CONTACT","4126240422","piya.dasghatak@pitt.edu",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Shomita S Steiner, PhD, MS","463•236•8770","SSTEINER@pitt.edu",[27,49],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"University of Arizona","RECRUITING","Tucson","Arizona","85724","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-110.92648,32.22174,{"lat":39,"lon":38},[42,46],{"name":43,"role":19,"phone":44,"phoneExt":10,"email":45},"Fleur Maturo","520-621-8296","fleurmartinez@arizona.edu",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},"Geoffrey C. Gurtner, MD","SUB_INVESTIGATOR",{"facility":50,"status":29,"city":51,"state":52,"zip":53,"country":33,"countryCode":34,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"UPMC Wound Healing Services at UPMC Passavant","Cranberry Township","Pennsylvania","16066",{"type":36,"coordinates":55},[56,57],-80.10714,40.68496,{"lat":57,"lon":56},[60],{"name":61,"role":15,"phone":10,"phoneExt":10,"email":10},"Chandan K Sen, Phd",{"type":15,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Chandan Sen","Professor",[66,69],{"name":67,"class":68},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":28,"class":6},"100452483","diabetic-foot-ulcer-dfu-biofilm-infection-and-recurrence-100452483",false,"NCT05172089","Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence","DFUBiofilm","Inclusion Criteria:\n\n* Male or Female, Age ≥ 18\n* Willing to comply with protocol instructions, including all study visits and study activities.\n* Patient with an open Diabetic Foot Ulcer\n* Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):\n* TcOM \\>30 mmHg\n* Ankle-brachial index at least ≥0.7\n* Toe pressure \\> 30 mmHg\n* TBI \\> 0.6 mmHg\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.\n* Wounds closed or to be surgically closed by flap or graft coverage\n* Subjects with marked immunodeficiency (HIV\u002FAIDS, or on immunosuppressive medications.\n* TcOM \\\u003C 30mmHg\n* Diabetics with a hemoglobin A1c \\> 15 within 3 months prior to enrollment\n* Subject with autoimmune connective tissue disease\n* Ulcer size and location that does not allow the TEWL measurement per SOP\n* Pregnant women\n* Prisoners\n* Unable to comply with study procedures and\u002For complete study visits","ALL","18 Years",{"count":80,"type":81},405,"ESTIMATED","OBSERVATIONAL","This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.",[85,86,87,88,89],"Chronic Wounds","Biofilm Infection","Trans-epidermal Water Loss (TEWL)","Diabetic Foot","Diabetic Foot Infection",[91,92,93,94],"foot ulcer","diabetic foot","wound infection","diabetic foot ulcer","2026-03-14",{"date":97,"type":98},"2026-03-18","ACTUAL",{"date":100,"type":98},"2024-04-02",{"date":102,"type":81},"2029-06-27",{"name":5,"class":6},2]