A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them

Status: Recruiting
Location: See location...
Intervention Type: Other
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
US Wound Registry
RECRUITING
The Woodlands
Contact Information
Primary
Caroline E Fife, MD
cfife@USwoundregistry.com; cfife@intellicure.com
800-603-7896
Backup
Ben LeBoutillier, MS
bLeBoutillier@intellicure.com
800-603-7896
Time Frame
Start Date: 2005-01-01
Estimated Completion Date: 2030-01
Participants
Target number of participants: 300000
Treatments
chronic wound patients
This cohort includes pediatric and adult patients with one or more chronic wounds or ulcers treated in any site of care including hospital outpatient clinics, office-based practices, skilled nursing, and home. Data are captured prospectively during routine care using a purpose built certified EHR. Wounds include diabetic foot ulcers, venous leg ulcers, pressure ulcers/injuries, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Interventions are at the discretion of the treating clinician and include standard and advanced wound therapies. Data collected include patient demographics, comorbid conditions, medications, total number of concomitant wounds per patient, wound characteristics, treatments, visit frequency, complications, and outcomes including healing, amputation, recurrence, hospitalization, and death. Patients may be followed for over five years.
Sponsors
Leads: U.S. Wound Registry

This content was sourced from clinicaltrials.gov

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