A Real-World Registry of Chronic Wounds and Ulcers
NCT02280733 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300000
Last updated 2025-07-16
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.
Conditions
- 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
Interventions
- OTHER
-
Usual care
advanced dressings, off-loading, venous ulcer compression, arterial screening
Sponsors & Collaborators
-
U.S. Wound Registry
lead OTHER
Principal Investigators
-
Caroline E Fife, MD · Intellicure LLC
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-01
- Primary Completion
- 2030-01-31
- Completion
- 2030-01-31
Countries
- United States
Study Locations
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