[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02280733":3,"trial-entities:NCT02280733":167,"trial-summary:NCT02280733":178},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":39,"study_type":68,"primary_purpose":69,"phases":70,"enrollment_info":71,"interventions":74,"primary_outcomes":82,"secondary_outcomes":96,"sex":101,"minimum_age":69,"maximum_age":69,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":113,"locations":117,"central_contacts":133,"overall_officials":139,"references":143,"see_also_links":163},"NCT02280733","USWR 001","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","RECRUITING","2030-01","2025-07","2025-07-16","2005-01-01","U.S. Wound Registry","OTHER",true,"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.","WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic disease burden and patient journey of individuals with chronic wounds and ulcers. Data collection began in 2005 and continues prospectively, capturing structured clinical data at the point of care using a purpose-built certified EHR or EDC system. These data are securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified Clinical Data Registry (QCDR).\n\nAll major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers\u002Finjuries, Surgical complications, Traumatic wounds, Vasculitic\u002Finflammatory, and sickle cell-related ulcers, and chronic non-pressure ulcers.\n\nThe registry collects detailed data on standard-of-care practices and advanced wound care interventions, including brand-specific information on: Advanced dressings (e.g., collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and\u002For tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products (CAMPs) or \"skin substitutes,\" Negative pressure wound therapy, MIST therapy (low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy (HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement, Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other treatments.\n\nThe registry captures key elements of the patient journey, including: Frequency of debridement, Sites of care, number of patient visits and number of wound visits, Dressing changes, Use and timing of advanced therapies, Comorbid disease burden and clinical complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in service, wound time service, patient and wound outcomes, the development of new wounds while in service and complication rates.\n\nWounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment and longitudinal outcome tracking. Follow-up may extend over five years, capturing outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is assessed using wound-specific quality measures. The registry integrates real-world clinical care with research and quality improvement, supporting a learning healthcare system model.\n\nThrough secure tokenization, registry data may be linked to payer claims for comprehensive longitudinal analysis of healthcare utilization, interventions, hospitalizations, medication use, and long-term outcomes across care settings. This enables rigorous, policy-relevant evaluations of standard care and advanced wound therapies in routine practice. The robust patient and wound level data are suitable to understand the natural history of chronic wounds and ulcers and to create historical controls for prospective clinical trials.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Diabetic Foot","Pressure Ulcer","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","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds","Chronic Ulcer",[40,41,42,43,44,45,46,47,20,34,48,49,28,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Diabetic Foot Ulcer","Venous Leg Ulcer","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)","Debridement","Standard of Care","OBSERVATIONAL",null,[],{"count":72,"type":73},300000,"ESTIMATED",[75],{"type":14,"name":76,"description":77,"armGroupLabels":78,"otherNames":80},"Usual care","advanced dressings, off-loading, venous ulcer compression, arterial screening",[79],"chronic wound patients",[81],"usual and customary care",[83,87,90,93],{"measure":84,"description":85,"timeFrame":86},"Healed","Wound closure by secondary intention","1 year",{"measure":88,"description":89,"timeFrame":86},"Major amputation","Below the knee, above the knee",{"measure":91,"description":92,"timeFrame":86},"Minor amputation","toe amputation, transmetatarsal amputation, midfoot amputation",{"measure":94,"description":95,"timeFrame":86},"Patient Death","patient death while in treatment",[97],{"measure":98,"description":99,"timeFrame":100},"Percent surface area (PAR) reduction over time","Percent surface area reduction (PSAR) is defined as the percentage decrease in wound surface area from the initial documented size at baseline (first qualifying wound care visit) to subsequent visits over time. Wound surface area is measured using length × width, captured at the point of care using structured fields within the electronic health record (EHR) or electronic data capture (EDC) system. Values are recorded in cm² and used to calculate PSAR as:\n\n\\[(Baseline area - Follow-up area) ÷ Baseline area\\] × 100\n\nThis metric is assessed at multiple time intervals, including 4 weeks, 12 weeks, 16 weeks, 6 months, and 12 months. PSAR is a key performance indicator for healing trajectory and is used to evaluate response to interventions. All wound types are included, and multiple wounds per patient are analyzed independently. Surface area measurements are case-mix adjusted using the Wound Healing Index for comparative effectiveness and quality reporting.","variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 52 weeks)","ALL",false,{"inclusion":104,"exclusion":111,"raw_text":112},[105,106,107,108,109,110],"Presence of one or more chronic wounds or ulcers of any etiology","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.)","Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system","All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)","All sexes and gender identities","All wound types and severities, including multiple wounds per patient",[],"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)",[114,115,116],"CHILD","ADULT","OLDER_ADULT",[118],{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":130},"US Wound Registry","The Woodlands","Texas","77386","United States",[125],{"name":126,"role":127,"phone":128,"email":129},"Caroline E Fife, MD","CONTACT","800-603-7896","cfife@intellicure.com",{"lat":131,"lon":132},30.15799,-95.48938,[134,136],{"name":126,"role":127,"phone":128,"email":135},"cfife@USwoundregistry.com; cfife@intellicure.com",{"name":137,"role":127,"phone":128,"email":138},"Ben LeBoutillier, MS","bLeBoutillier@intellicure.com",[140],{"name":126,"affiliation":141,"role":142},"Intellicure LLC","PRINCIPAL_INVESTIGATOR",[144,148,151,154,157,160],{"pmid":145,"type":146,"citation":147},"18577134","BACKGROUND","Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111\u002Fj.1742-481X.2008.00467.x.",{"pmid":149,"type":146,"citation":150},"24761335","Fife CE, Walker D, Thomson B. Electronic Health Records, Registries, and Quality Measures: What? Why? How? Adv Wound Care (New Rochelle). 2013 Dec;2(10):598-604. doi: 10.1089\u002Fwound.2013.0476.",{"pmid":152,"type":146,"citation":153},"24134202","Horn SD, Fife CE, Smout RJ, Barrett RS, Thomson B. Development of a wound healing index for patients with chronic wounds. Wound Repair Regen. 2013 Nov-Dec;21(6):823-32. doi: 10.1111\u002Fwrr.12107. Epub 2013 Oct 17.",{"pmid":155,"type":146,"citation":156},"20375969","Carter MJ, Fife CE, Walker D, Thomson B. Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials. Adv Skin Wound Care. 2009 Jul;22(7):316-24. doi: 10.1097\u002F01.ASW.0000305486.06358.e0.",{"pmid":158,"type":146,"citation":159},"20368672","Fife CE, Carter MJ, Walker D, Thomson B. A retrospective data analysis of antimicrobial dressing usage in 3,084 patients. Ostomy Wound Manage. 2010 Mar 1;56(3):28-42.",{"pmid":161,"type":146,"citation":162},"20163568","Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Repair Regen. 2010 Mar-Apr;18(2):154-8. doi: 10.1111\u002Fj.1524-475X.2010.00571.x. Epub 2010 Feb 16.",[164],{"label":165,"url":166},"US Wound Registry Website","http:\u002F\u002Fwww.uswoundregistry.com\u002F",{"nct_id":4,"conditions":168,"biomarkers":177},[30,169,170,27,171,172,173,31,174,175,49,22,176],"Chronic ulcer","Diabetic foot ulcer","Peripheral Artery Disease","Pressure Sore","Pyoderma gangrenosum","Soft Tissue Radionecrosis","Stasis ulcer","Wound Breakdown",[],{"nct_id":4,"found":15,"summary":179,"prompt_version":189},{"design":180,"status":181,"heading":182,"summary":183,"follow_up":184,"word_count":185,"commitments":186,"compensation":187,"drugs_mentioned":188},"This is an observational registry study, not testing a specific intervention, and plans to include 300,000 participants. It collects data during routine care from over 1,400 clinicians.","completed","Real-World Registry of Chronic Wounds and Ulcers","This is an observational study, called WOUNDJOURNEY, that collects information about people with chronic wounds or ulcers, such as diabetic foot ulcers, pressure ulcers, or surgical wounds. It's not testing a new treatment, but rather observing how different types of chronic wounds are treated in real-world settings across the USA and Puerto Rico. The study aims to understand the full journey of patients with these wounds. Researchers will look at whether wounds heal, and if major or minor amputations are needed, all measured at one year. You could be included if you have one or more chronic wounds or ulcers of any type, and your care is documented at a participating clinic using a special electronic health record system. The study is ongoing and has been collecting data since 2005.","The primary outcomes, such as healing and amputations, are measured at one year.",130,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]