RECRUITING

A Real-World Registry of Chronic Wounds and Ulcers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2005-01-01
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02280733

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presence of one or more chronic wounds or ulcers of any etiology
  2. * 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.)
  3. * Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system
  4. * All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)
  5. * All sexes and gender identities
  6. * All wound types and severities, including multiple wounds per patient
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Caroline E Fife, MD
CONTACT
800-603-7896
cfife@USwoundregistry.com; cfife@intellicure.com
Ben LeBoutillier, MS
CONTACT
800-603-7896
bLeBoutillier@intellicure.com

Principal Investigator

Caroline E Fife, MD
PRINCIPAL_INVESTIGATOR
Intellicure LLC

Study Locations (Sites)

US Wound Registry
The Woodlands, Texas, 77386
United States

Collaborators and Investigators

Sponsor: U.S. Wound Registry

  • Caroline E Fife, MD, PRINCIPAL_INVESTIGATOR, Intellicure LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2005-01-01
Study Completion Date2030-01

Study Record Updates

Study Start Date2005-01-01
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • Qualified Clinical Data Registry
  • Quality Measures
  • Clinical Data Research Network
  • Real world data
  • chronic wounds
  • chronic ulcers
  • Diabetic Foot Ulcer
  • Venous Leg Ulcer
  • Pressure Ulcer
  • Pressure Injury
  • Arterial Ulcer
  • Traumatic Wound
  • Surgical Complication
  • Pyoderma Gangrenosum
  • Advanced Wound Care
  • Skin Substitutes
  • CAMPs
  • CTPs
  • Negative Pressure Wound Therapy
  • NPWT
  • Collagen Dressings
  • Compression Therapy
  • Hyperbaric Oxygen Therapy
  • Wound Debridement
  • Real-World Evidence
  • Comparative Effectiveness
  • Wound Healing
  • Amputation
  • Electronic Health Record (EHR)
  • Debridement
  • Standard of Care

Additional Relevant MeSH Terms

  • 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