RecruitingNCT02280733

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

Sponsor

U.S. Wound Registry

Enrollment

300,000 participants

Start Date

Jan 1, 2005

Study Type

OBSERVATIONAL

Summary

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.

Eligibility

Inclusion Criteria6

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

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