A Real-World Registry of Chronic Wounds and Ulcers

Part of paid clinical trials in The Woodlands, Texas.

Sponsor
U.S. Wound Registry
Study ID
NCT02280733
Status
Recruiting
Apply to this trial

Conditions

  • Arterial Ulcers
  • Calciphylaxis
  • Chronic Ulcer
  • Diabetic Foot
  • Diabetic Foot Ulcers (DFUs)
  • Leg Ulcer
  • Lymphedema
  • Peripheral Arterial Disease
  • Pressure Injury
  • Pressure Ulcer
  • Pressure Ulcer (PU)
  • Pyoderma
  • Sickle Cell Ulcer
  • Skin Ulcer
  • Soft Tissue Radionecrosis (STRN)
  • Surgical Complication
  • Surgical Wound Dehiscence
  • Traumatic Wounds
  • Vasculitis
  • Venous Leg Ulcers (VLUs)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual care — OTHER
    advanced dressings, off-loading, venous ulcer compression, arterial screening

Study Details

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.

Key Dates

Start date
Jan 1, 2005
Status verified
Jul 2025
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
300,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Healed [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
US Wound RegistryThe WoodlandsTexas77386
Caroline E Fife, MD
[email protected]
800-603-7896

Find similar trials in The Woodlands, TX

By research site
US Wound Registry· The Woodlands, TX

Related Studies