A Real-World Registry of Chronic Wounds and Ulcers
Recruiting · NCT02280733 · Observational (researchers observe without assigning treatment) · Lead sponsor: U.S. Wound Registry
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)
Where it is running
1 location listed across 1 US state.
- US Wound Registry - The Woodlands, Texas, United States