[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"open-wound\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:open-wound":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100586683","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-chronic-open-wounds-100586683",false,"NCT06918561","Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds","A Randomized Controlled Multisite Crossover Trial Evaluating the Efficacy of NeoThelium FT in the Treatment of \"Other\" Open Wounds","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of \"other\" Open wound\n3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening\n5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has an Open wound without infection or clinically visible exposed bone\n7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit\n8. Index ulcer has a maximum depth of 1cm at screening visit 1\n9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization\n10. Adequate circulation of wounds located below the knee demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n11. Index ulcer is free of infection prior to randomization and during screening phase.\n12. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n15. Subject is able and willing to follow the protocol requirements\n16. Subject had signed informed consent\n17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than \"open wound\"\n2. Subject has a known life expectancy of \\\u003C1 year\n3. Subject is unable to comply with protocol treatment\n4. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications to tissue-engineered allograft\n8. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Open wound with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index wound leg within 30 days of screening phase\n16. Index wound suspicious of neoplasm in the opinion of the principal investigator","ALL","18 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating chronic open wounds.",[26],"Open Wound",[28,29,30,31,32],"Chronic wounds","Wound Medicine","Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2025-10-16",{"date":41,"type":20},"2026-10-01",{"name":43,"class":44},"NuScience Medical Biologics, LLC","INDUSTRY",14,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100623418","phase-1-evaluation-of-elu42-topical-spray-for-the-treatment-of-diabetic-foot-ulcers-100623418","NCT07396376","Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers","Protocol ELU42 01 01: Phase I\u002FIIA, Open Label, Single Arm Evaluation of Topical ELU42 (XAV939 in DHA77) for Wagner Grade 1-2 Diabetic Foot Ulcers","Inclusion Criteria:\n\n* Age 18 to ≤75 years;\n* Diagnosis of type 1 or type 2 diabetes mellitus;\n* A1C ≤ 10 (historical within 2 months accepted);\n* BMI ≤ 36;\n* Index DFU Wagner grade 1-2 with post debridement area ≥1.0 cm2 and ≤8.0 cm2;\n* Index DFU present for 4-52 weeks;\n* Index ulcer ≥1 cm below malleoli;\n* Adequate perfusion per ABI\u002FTcPO2\u002FPVR\u002FTBI or Doppler; plantar ulcers off loaded ≥14 days prior to treatment;\n* Ability to consent and attend visits;\n* Contraception requirements for females of childbearing potential.\n\nExclusion Criteria:\n\n* Infected index ulcer or surrounding cellulitis;\n* Ischemic ulcers; osteomyelitis or exposed bone;\n* Recent systemic antibiotic requirement for active infection (eligibility after resolution and 7 day washout);\n* Acute\u002Finactive Charcot preventing off loading; hemoglobin \\\u003C 10 g\u002FdL (unless Sponsor approves);\n* ESRD requiring dialysis;\n* Recent\u002Fplanned vascular procedure on target leg within 30 days;\n* Participation in other IP trials within 30 days;\n* Active alcohol\u002Fsubstance abuse within 3 months;\n* Pregnancy or lactation;\n* Other PI judged exclusions","75 Years",{"count":55,"type":20},15,[57,58],"PHASE1","PHASE2","ELU42 01 01 (SuperHealer42) is a Phase I\u002FIIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the treatment of chronic diabetic foot ulcers (DFU). ELU42 combines a tankyrase inhibitor (XAV939) with a novel derivatized hyaluronic acid excipient (DHA77) and is applied as a topical spray to the index ulcer.\n\nFifteen adults with Wagner grade 1-2 diabetic foot ulcers that have been present for at least 4 weeks and up to 52 weeks will be enrolled across up to four U.S. clinical sites. After a 2 week run in period during which standard of care (SOC) is provided (off loading, dressings, and debridement), subjects will receive ELU42 applied on site by trained study staff or the investigator three times per week (Monday, Wednesday, Friday) for six weeks (up to 18 applications). Subjects will be followed weekly during treatment and for up to 6 weeks after the final dose; additional Healing Confirmation visits are scheduled if the wound closes to evaluate the subjects over a course of a 3 month period.\n\nThe study's co-primary objectives are to assess safety (incidence and severity of adverse events and infections) and to measure percent area reduction (PAR) of the index ulcer at Weeks 4 and 6. Efficacy assessments will be performed by the site investigator using direct two axis planimetry and by automated evaluation using the Tissue Analytics platform (surface area, volume, and PAR). Secondary and exploratory assessments include patient reported outcomes (Wound Q and SF 36), frequency of complete wound healing, wound hydration metrics, and pharmacokinetic sampling in a subset of subjects.\n\nContact information for potential participants and referring clinicians is available at each participating site.",[61,62,63,26],"Diabetic Foot Ulcer","Wagner Grade 1 - 2","Chronic Wound",[65,63,66,26,67],"Wagner 1 and 2 Ulcer","DFU","Wound Healing","2026-02-10",{"date":70,"type":37},"2026-02-12",{"date":72,"type":37},"2025-11-10",{"date":74,"type":20},"2026-06-01",{"name":76,"class":44},"Eluciderm Inc",4,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100452308","early-phase-1-micronanobubbles-mnbs-for-treatment-of-acute-and-chronic-wounds-100452308","NCT05169814","Micro\u002FNanobubbles (MNBs) for Treatment of Acute and Chronic Wounds","Micro\u002FNanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds","MNB","Inclusion Criteria:\n\n* are above the age of 18.\n* have traumatic, surgical, or chronic wounds.\n* have radiotherapy related tissue injury.\n* have thermal, chemical, and\u002For electrical burn injuries.\n* have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, and\u002For neuropathic skin ulcers.\n* have acute ischemic wounds\n\nExclusion Criteria:\n\n* have infected wounds.\n* have wounds with exposed vital structures such as nerves, arteries, and\u002For veins.\n* have wounds associated with malignancy.",{"count":87,"type":20},40,[89],"EARLY_PHASE1","The purpose of this study is to assess the safety and efficacy of Micro\u002Fnanobubbles (MNB's) for the healing of acute and chronic wounds.",[26,92],"Wound Heal",[94,95,96,84,97,98,99],"acute wounds","chronic wounds","MNB solution","Micro\u002Fnanobubbles","Micronanobubbles","negative pressure wound therapy with instillation","2025-09-26",{"date":102,"type":37},"2025-10-02",{"date":104,"type":37},"2021-10-09",{"date":106,"type":20},"2027-06-01",{"name":108,"class":109},"University of California, Irvine","OTHER",1]