Recruiting

Observational Study

Sponsor:

U.S. Wound Registry

Code:

NCT02280733

Conditions

Diabetic Foot

Pressure Ulcer

Surgical Wound Dehiscence

Vasculitis

Skin Ulcer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Usual care

Study Details

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.

Conditions

Diabetic Foot

Pressure Ulcer

Surgical Wound Dehiscence

Vasculitis

Skin Ulcer

Study ID

NCT02280733

Start date

Jan 1, 2005

Status verified date

Jul, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Usual care

advanced dressings, off-loading, venous ulcer compression, arterial screening

Primary outcome measure

  • Healed [ Time Frame: 1 year ]
  • Major amputation [ Time Frame: 1 year ]
  • Minor amputation [ Time Frame: 1 year ]
  • Patient Death [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Caroline E Fife, MD

800-603-7896cfife@USwoundregistry.com; cfife@intellicure.com

Ben LeBoutillier, MS

800-603-7896bLeBoutillier@intellicure.com

Locations

US Wound Registry

Recruiting

The Woodlands, Texas, United States, 77386

Contacts

Caroline E Fife, MD

800-603-7896cfife@intellicure.com

More Information

Sponsor

U.S. Wound Registry

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by U.S. Wound Registry on 2025-07-16.