[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-wounds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-wounds":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,76,100,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100639478","theravex-tissue-care-spray-plus-for-the-management-of-cutaneous-wounds-burns-and-chronic-ulcers-100639478",false,"NCT07617961","THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers","Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers","Inclusion Criteria\n\nAdult patients aged 18 years or older. Patients presenting with cutaneous wounds: burns, traumatic wounds, pressure ulcers, diabetic ulcers, or chronic cutaneous lesions.\n\nPatients considered clinically suitable for topical treatment with THERAVEX Tissue Care Spray Plus.\n\nExclusion Criteria Known allergy or hypersensitivity to any component of THERAVEX Tissue Care Spray Plus.\n\nPresence of severe uncontrolled systemic infection requiring immediate surgical intervention.\n\nParticipation in another interventional clinical study that could interfere with wound healing assessment.",true,"ALL","18 Years",{"count":20,"type":21},26,"ESTIMATED","OBSERVATIONAL","Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response, tolerance, and overall clinical evolution in patients receiving standard wound care combined with topical application of THERAVEX Tissue Care Spray Plus. Preliminary observations demonstrated favorable tissue response, progressive epithelial regeneration, reduction of inflammatory signs, and absence of treatment-related adverse events.",[25,26,27,28,29],"Chronic Wounds","Burns","Pressure Ulcer","Traumatic Wounds","Diabetic Foot Ulcer","RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-04","ACTUAL",{"date":36,"type":34},"2025-10-02",{"date":38,"type":21},"2027-05-21",{"name":40,"class":41},"Biointelligent Technology Systems SL","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100616968","multicenter-randomized-non-inferiority-study-to-compare-the-performance-and-safety-of-debrisoft-duo-with-debrisoft-pad-in-the-debridement-of-wounds-100616968","NCT07312513","Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient is legally capable\n* Patient has signed written informed consent\n* Presence of one of the following wounds\n\n  * Venous lower leg ulcer\n  * Arterial ulcer\n  * Diabetic ulcer\n  * Pressure ulcer\n  * Post-operative wound healing by secondary intention\n  * Traumatic wound\n  * Surgical wound\n  * Burn or scald (grade III: after surgical debridement)\n  * Epidermolysis Bullosa\n* Wound area \\>4cm2\n* The entire wound area can be displayed on one photo from a distance of 25-30 cm\n* Covered with at least 30% debris, necrosis, slough, fibrotic tissue\n\nExclusion Criteria:\n\n* Known allergy and\u002For hypersensitivity to Debrisoft® Duo or any of the product components\n* Pregnancy or breast feeding\n* Patient is illiterate\n* Participation in a interventional clinical trial within the last 14 days and during participation in this study\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and\u002F or interpretation of the study results\n* severe pain or hyperesthesia in the wound area\n* history of drug or alcohol abuse\n* chronic analgesic use (especially opioids) that could influence baseline pain perception\n* cognitive impairment, which may affect the ability to accurately self-report pain\n* Use of anaesthesia before the debridment procedure\n* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary",{"count":50,"type":21},104,"INTERVENTIONAL",[53],"NA","The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.",[56,57,58,59,60,61,62,28,63],"Diabetic Ulcers","Arterial Ulcers","Venous Ulcers","Pressure Ulcers","Postoperative Wounds Healing by Secondary Intention","Burns and Scalds","Epidermolysis Bullosa (EB)","Surgical Wounds",[65,66],"Debridement","mechanical debridement","2025-12-17",{"date":69,"type":34},"2025-12-31",{"date":71,"type":34},"2025-05-09",{"date":73,"type":21},"2026-02",{"name":75,"class":41},"Lohmann & Rauscher",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":51,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":42},"100612619","pmcf-study-of-debridement-pad-100612619","NCT07255937","PMCF Study of Debridement Pad","Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds","Inclusion Criteria:\n\n* Males or females aged 18 years or above.\n* Patients who can understand and give informed consent to take part in the study.\n* Have one or more of the following wounds: Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds\n* Wounds that require debridement due to the presence of slough debris\u002Ffibrous tissue ,hyperkeratotic debris and dried exudate on the peri wound skin.\n* Wounds with both serous crusts and healthy tissue.\n* Minimum of 30% of the wound covered by debris, necrosis or slough.\n* Wound Size \\> 4cm2\n\nExclusion Criteria:\n\n* Patients who are known to be non-compliant with medical treatment\n* Patients who are known to be sensitive to any of the device components such as polyester.\n* Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study.\n* Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.\n* Symptoms \\& signs of systemic and \u002F or spreading wound infection (including erythema and fever).\n* Severe pain (level 7 or higher on a 0-10 VAS or hyperaesthesia in the wound area).\n* Subjects who in the view of the investigator might not be suitable for inclusion in the study",{"count":84,"type":21},184,[53],"The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.",[56,88,89,27,90,28,63,61],"Venous Leg Ulcer","Arterial Leg Ulcer","Postoperative Wound Healing","2025-11-27",{"date":93,"type":34},"2025-12-01",{"date":95,"type":34},"2025-11-20",{"date":97,"type":21},"2026-07-10",{"name":99,"class":41},"Advanced Medical Solutions Ltd.",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":22,"phases":4,"briefSummary":111,"conditions":112,"keywords":130,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":42},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679","NCT02280733","A Real-World Registry of Chronic Wounds and Ulcers","A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them","WOUNDJOURNEY","Inclusion Criteria:\n\n* Presence of one or more chronic wounds or ulcers of any etiology\n* Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)\n* Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system\n* All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)\n* All sexes and gender identities\n* All wound types and severities, including multiple wounds per patient\n\nExclusion Criteria:\n\n-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)",{"count":109,"type":21},300000,"5 Years","WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.",[113,27,114,115,116,117,118,119,120,121,122,123,124,125,126,127,57,128,28,129],"Diabetic Foot","Surgical Wound Dehiscence","Vasculitis","Skin Ulcer","Leg Ulcer","Pyoderma","Peripheral Arterial Disease","Lymphedema","Surgical Complication","Venous Leg Ulcers (VLUs)","Calciphylaxis","Sickle Cell Ulcer","Pressure Ulcer (PU)","Diabetic Foot Ulcers (DFUs)","Pressure Injury","Soft Tissue Radionecrosis (STRN)","Chronic Ulcer",[131,132,133,134,135,136,29,88,27,127,137,138,121,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,65,155],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","Advanced Wound Care","Skin Substitutes","CAMPs","CTPs","Negative Pressure Wound Therapy","NPWT","Collagen Dressings","Compression Therapy","Hyperbaric Oxygen Therapy","Wound Debridement","Real-World Evidence","Comparative Effectiveness","Wound Healing","Amputation","Electronic Health Record (EHR)","Standard of Care","2025-07-10",{"date":158,"type":34},"2025-07-16",{"date":160,"type":34},"2005-01-01",{"date":162,"type":21},"2030-01",{"name":164,"class":165},"U.S. Wound Registry","OTHER",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":51,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":42},"100433140","real-world-evidence-with-the-debritom-tm-novel-micro-water-jet-technology-at-a-single-wound-center-100433140","NCT04920253","Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center","EVIDENT","Inclusion Criteria:\n\nGeneral\n\nPotential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization:\n\n1. At least 18 years old.\n2. The index wound (i.e. current episode of the wound or ulceration) has been present for greater than 4 weeks prior to SV 1 and has had less than 1 year of documented medical treatment, as of the subject's consent for the study participation.\n3. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1.\n4. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.\n5. Subject must have read and signed the IRB approved Informed Consent Form (ICF) before study specific screening procedures that are not standard of care are undertaken.\n\n   DFU\n6. Presence of diabetic foot ulcer (DFU) that meets all of the following features:\n7. Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend to the ligament, tendon, joint capsule or fascia\n8. Without abscess or osteomyelitis\n9. The index ulcer will be the largest ulcer if two or more DFUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2cm distant from index ulcer (edge to edge).\n10. The index ulcer has been offloaded for at least 14 days prior to randomization\n11. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular Assessment Tool, or an Ankle Brachial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed, evaluating for bi-phasic dorsalis pedis and posterior tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave forms present must have adequate micro circulation as evidenced by Clarifi SFDI Vascular Assessment Tool. Note: A documented record of an ABI test performed using the index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study. Otherwise, this must be completed in the Screening Visit. Acceptable alternatives include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or documented adequate microcirculation as determined by a Clarifi SFDI Vascular Assessment Tool.\n\n    VLU\n12. All wounds using the CEAP VLU Classification, except for those in the exclusion criteria. (See Appendix A for definitions)\n13. The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other Ulcerations are present on the same leg, they must be more than 2cm distant from index ulcer.\n14. Adequate circulation to the affected foot as documented by a Clarifi SFDI Vascular Assessment Tool, or an Ankle Brachial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed, evaluating for bi-phasic dorsalis pedis and posterior tibial vessels at the level of the ankle within 3 months of SV1 or if monophasic wave forms present must have adequate micro circulation as evidenced by Clarifi SFDI Vascular Assessment Tool. Note: A documented record of an ABI test performed using the index ulcer leg, within 3 months of SV1 is acceptable for the purposes of this study. Otherwise, this must be completed in the Screening Visit. Acceptable alternatives include arterial Doppler ultrasound evaluating vessels at the level of the ankle, or documented adequate microcirculation as determined by a Clarifi SFDI Vascular Assessment Tool.\n\n    Surgical Dehisced\n15. All wounds using the Sandy Grading System, except those in the exclusion criteria. (See Appendix A for definitions)\n\n    Traumatic\n16. All wounds as per the CDC Surgical Wound Classification, with the exception of Class IV or dirty infected wounds, SSI - Deep incisional and organ space. (See Appendix A for definitions)\n\nExclusion Criteria:\n\nGeneral\n\nPotential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization:\n\n1. The index wound, in the opinion of the investigator, is suspicious for cancer or have a positive carcinoma diagnosis.\n2. Subject has a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the wound surface within 1 month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.\n3. Subject is taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.\n4. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.\n5. History of radiation at the wound site (regardless of time since last radiation treatment).\n6. Index wound has been previously treated or will need to be treated with any prohibited therapies (See Section 6 of this protocol for a list of prohibited medications and therapies).\n7. Subject has a previous diagnosis of HIV, Hepatitis C, or other contagious diseases.\n8. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or the subject has a known history of poor adherence with medical treatment.\n9. Subject is pregnant or breast-feeding.\n10. Presence of diabetes with poor metabolic control as documented with an HbA1c \\>12.0 % within 90 days of randomization.\n11. Subject has end-stage renal disease as evidenced by a serum creatinine \\> 3.0mg\u002FdL within 6 months of randomization.\n12. BMI \\>55\n13. PAR experiences a \\>30% change between SV1 and SV2 DFU\n14. Wagner 2 wounds that require debridement of bone.\n15. Osteomyelitis or bone infection of the affected foot as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).\n\n    VLU\n16. Exclude\n\n    1. Secondary post thrombotic\n    2. Venous Obstruction\n    3. Venous Obstruction with reflux\n    4. Lipodermato sclerosis or atrophic blanche\n17. Osteomyelitis or bone infection of the affected leg as verified by x-ray, CAT Scan, or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).\n\n    Surgical Dehisced\n18. Using the Sandy Grading System for Surgical Wound Dehiscence: Wounds Grade 3 where organs are exposed, and 3a, where the infection is severe as deemed by the Principal Investigator.\n\n    Traumatic\n19. Using CDC Surgical Wound Classification, exclude\n\n    1. Class IV - dirty infected wounds\n    2. SSI - Deep incisional and organ space",{"count":174,"type":21},180,[53],"Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.",[29,88,114,28],"2024-11-19",{"date":180,"type":34},"2024-11-21",{"date":182,"type":34},"2021-11-29",{"date":184,"type":21},"2025-12",{"name":186,"class":41},"Medaxis, LLC"]