[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05172089":3,"trial-entities:NCT05172089":118,"trial-summary:NCT05172089":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":35,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":29,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":70,"locations":73,"central_contacts":104,"overall_officials":113,"references":116,"see_also_links":117},"NCT05172089","STUDY23050116","Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence","RECRUITING","2029-06-27","2026-03","2026-03-18","2024-04-02","University of Pittsburgh","OTHER",true,"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.","Diabetic foot ulcers (DFU) are one of the most common reasons for hospitalization of diabetic patients and frequently results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of amputation in patients with DFU is 38.4%4. Infection is a common (\\>50%) complication of DFU. Emerging evidence underscores the significant risk that biofilm infection poses to the non-healing DFU. Biofilms are estimated to account for 60% of chronic wound infections. In the biofilm form, bacteria are in a dormant metabolic state. Thus, standard clinical techniques like the colony forming unit (CFU) assay to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent maleficent threat in wound care.\n\nn the current standard of care (SoC), wound closure is defined (FDA) by wound area re-epithelialization without drainage. The investigators' pre-clinical large animal work demonstrates that wounds with a history of biofilm infection may meet above criteria, but the repaired wound-site skin is deficient in barrier function. This has led to the concept of functional wound closure wherein the current clinical definition of wound closure is supplemented with a functional parameter - restoration of skin barrier function as measured by low trans-epidermal water loss (TEWL).\n\nThis study rests pilot study showing that closed DFU with deficient barrier function are more likely to recur. Biofilm infection as assessed through scanning electron microscopy and wheat germ agglutin assay performed on debrided tissue causes faulty re-epithelialization, compromising skin barrier function at the closed wound site. 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.",[18,19,20,21,22],"Chronic Wounds","Biofilm Infection","Trans-epidermal Water Loss (TEWL)","Diabetic Foot","Diabetic Foot Infection",[24,25,26,27],"foot ulcer","diabetic foot","wound infection","diabetic foot ulcer","OBSERVATIONAL",null,[],{"count":32,"type":33},405,"ESTIMATED",[],[36,40],{"measure":37,"description":38,"timeFrame":39},"Biofilm infection abundance","Test the incidence of wound biofilm infection at initial visit and test its association with deficient skin barrier function at the closed DFU-site","16 weeks",{"measure":41,"description":42,"timeFrame":43},"TEWL","Trans epidermal water loss post closure and 12 weeks","12 weeks",[],"ALL","18 Years",false,{"inclusion":49,"exclusion":58,"raw_text":69},[50,51,52,53,54,55,56,57],"Male or Female, Age ≥ 18","Willing to comply with protocol instructions, including all study visits and study activities.","Patient with an open Diabetic Foot Ulcer","Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):","TcOM \\>30 mmHg","Ankle-brachial index at least ≥0.7","Toe pressure \\> 30 mmHg","TBI \\> 0.6 mmHg",[59,60,61,62,63,64,65,66,67,68],"Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.","Wounds closed or to be surgically closed by flap or graft coverage","Subjects with marked immunodeficiency (HIV\u002FAIDS, or on immunosuppressive medications.","TcOM \\\u003C 30mmHg","Diabetics with a hemoglobin A1c \\> 15 within 3 months prior to enrollment","Subject with autoimmune connective tissue disease","Ulcer size and location that does not allow the TEWL measurement per SOP","Pregnant women","Prisoners","Unable to comply with study procedures and\u002For complete study visits","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",[71,72],"ADULT","OLDER_ADULT",[74,92],{"facility":75,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"University of Arizona","Tucson","Arizona","85724","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Fleur Maturo","CONTACT","520-621-8296","fleurmartinez@arizona.edu",{"name":87,"role":88},"Geoffrey C. Gurtner, MD","SUB_INVESTIGATOR",{"lat":90,"lon":91},32.22174,-110.92648,{"facility":93,"status":7,"city":94,"state":95,"zip":96,"country":79,"contacts":97,"geoPoint":101},"UPMC Wound Healing Services at UPMC Passavant","Cranberry Township","Pennsylvania","16066",[98],{"name":99,"role":100},"Chandan K Sen, Phd","PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},40.68496,-80.10714,[105,109],{"name":106,"role":83,"phone":107,"email":108},"Piya Das Ghatak, PhD, MS","4126240422","piya.dasghatak@pitt.edu",{"name":110,"role":83,"phone":111,"email":112},"Shomita S Steiner, PhD, MS","463•236•8770","SSTEINER@pitt.edu",[114],{"name":115,"affiliation":12,"role":100},"Chandan K Sen, PhD",[],[],{"nct_id":4,"conditions":119,"biomarkers":121},[120],"Diabetic foot ulcer",[],{"nct_id":4,"found":14,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an observational study planning to enroll 405 participants to understand factors related to diabetic foot ulcer healing and recurrence.","completed","Diabetic Foot Ulcer Biofilm Infection and Recurrence Study","This observational study is looking at people with open diabetic foot ulcers (DFU). Researchers want to understand if DFUs that have had a biofilm infection (a group of bacteria that stick together) heal with a weak skin barrier. They also want to see if this weak barrier, measured by how much water your skin loses (Trans-epidermal Water Loss or TEWL), leads to the wound coming back. The study will also explore the molecular reasons why biofilm infections might damage the skin's barrier. You can join if you are at least 18 years old, have an open DFU, and have good blood flow to your foot. The study aims to enroll 405 participants. The study is currently unclear on its recruitment status.","Biofilm infection abundance will be measured at 16 weeks, and Trans-epidermal Water Loss (TEWL) will be measured at 12 weeks.",121,"You would need to be willing to follow all study instructions, including attending all study visits and activities.","Not stated in the trial record.",[],"v2"]