NCT02280733 A Real-World Registry of Chronic Wounds and Ulcers
| NCT ID | NCT02280733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | U.S. Wound Registry |
| Condition | Diabetic Foot |
| Study Type | OBSERVATIONAL |
| Enrollment | 300,000 participants |
| Start Date | 2005-01-01 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300,000 participants in total. It began in 2005-01-01 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Caroline E Fife, MD
PRINCIPAL INVESTIGATOR
Intellicure LLC
Frequently Asked Questions
Who can join the NCT02280733 clinical trial?
This trial is open to participants of all sexes, studying Diabetic Foot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02280733 currently recruiting?
Yes, NCT02280733 is actively recruiting participants. Contact the research team at cfife@USwoundregistry.com; cfife@intellicure.com for enrollment information.
Where is the NCT02280733 trial being conducted?
This trial is being conducted at The Woodlands, United States.
Who is sponsoring the NCT02280733 clinical trial?
NCT02280733 is sponsored by U.S. Wound Registry. The principal investigator is Caroline E Fife, MD at Intellicure LLC. The trial plans to enroll 300,000 participants.