A Real-World Registry of Chronic Wounds and Ulcers

NCT02280733 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300000

Last updated 2025-07-16

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280733 on ClinicalTrials.gov