A Real-World Registry of Chronic Wounds and Ulcers (WOUNDJOURNEY)

July 10, 2025 updated by: U.S. Wound Registry

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic disease burden and patient journey of individuals with chronic wounds and ulcers. Data collection began in 2005 and continues prospectively, capturing structured clinical data at the point of care using a purpose-built certified EHR or EDC system. These data are securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified Clinical Data Registry (QCDR).

All major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers/injuries, Surgical complications, Traumatic wounds, Vasculitic/inflammatory, and sickle cell-related ulcers, and chronic non-pressure ulcers.

The registry collects detailed data on standard-of-care practices and advanced wound care interventions, including brand-specific information on: Advanced dressings (e.g., collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and/or tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products (CAMPs) or "skin substitutes," Negative pressure wound therapy, MIST therapy (low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy (HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement, Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other treatments.

The registry captures key elements of the patient journey, including: Frequency of debridement, Sites of care, number of patient visits and number of wound visits, Dressing changes, Use and timing of advanced therapies, Comorbid disease burden and clinical complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in service, wound time service, patient and wound outcomes, the development of new wounds while in service and complication rates.

Wounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment and longitudinal outcome tracking. Follow-up may extend over five years, capturing outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is assessed using wound-specific quality measures. The registry integrates real-world clinical care with research and quality improvement, supporting a learning healthcare system model.

Through secure tokenization, registry data may be linked to payer claims for comprehensive longitudinal analysis of healthcare utilization, interventions, hospitalizations, medication use, and long-term outcomes across care settings. This enables rigorous, policy-relevant evaluations of standard care and advanced wound therapies in routine practice. The robust patient and wound level data are suitable to understand the natural history of chronic wounds and ulcers and to create historical controls for prospective clinical trials.

Study Type

Observational

Enrollment (Estimated)

300000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • The Woodlands, Texas, United States, 77386
        • Recruiting
        • US Wound Registry
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic wounds or ulcers treated at participating sites in any US State and Puerto Rico. All patients and wounds are included without sampling. Each wound can be analyzed independently, even when multiple wounds exist on a single patient.

Sampling Method:

Non-Probability Sample

Minimum Age:

0 Years

Maximum Age:

None (patients aged 90+ are reported in aggregate per HIPAA)

Sex:

All

Gender Based:

No

Accepts Healthy Volunteers:

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Usual care
advanced dressings, off-loading, venous ulcer compression, arterial screening
Other Names:
  • usual and customary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healed
Time Frame: 1 year
Wound closure by secondary intention
1 year
Major amputation
Time Frame: 1 year
Below the knee, above the knee
1 year
Minor amputation
Time Frame: 1 year
toe amputation, transmetatarsal amputation, midfoot amputation
1 year
Patient Death
Time Frame: 1 year
patient death while in treatment
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent surface area (PAR) reduction over time
Time Frame: variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 52 weeks)

Percent surface area reduction (PSAR) is defined as the percentage decrease in wound surface area from the initial documented size at baseline (first qualifying wound care visit) to subsequent visits over time. Wound surface area is measured using length × width, captured at the point of care using structured fields within the electronic health record (EHR) or electronic data capture (EDC) system. Values are recorded in cm² and used to calculate PSAR as:

[(Baseline area - Follow-up area) ÷ Baseline area] × 100

This metric is assessed at multiple time intervals, including 4 weeks, 12 weeks, 16 weeks, 6 months, and 12 months. PSAR is a key performance indicator for healing trajectory and is used to evaluate response to interventions. All wound types are included, and multiple wounds per patient are analyzed independently. Surface area measurements are case-mix adjusted using the Wound Healing Index for comparative effectiveness and quality reporting.
variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 52 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Wound Registry

Investigators

  • Principal Investigator: Caroline E Fife, MD, Intellicure LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimated)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USWR 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) collected through the U.S. Wound Registry (USWR) may be made available to qualified researchers, payers, regulatory agencies, or industry partners upon request. Shared data may include demographics, comorbidities, wound characteristics, interventions, and outcomes captured longitudinally in a structured electronic health record (EHR) or data capture system. All shared data comply with HIPAA de-identification standards and may be subject to data use agreements and institutional review board (IRB) approval.

IPD Sharing Time Frame

Available upon request after data quality review and registry updates are complete. IPD is available on an ongoing basis, with no fixed end date.

IPD Sharing Access Criteria

Access to de-identified individual participant data (IPD) may be granted to qualified researchers, payers, regulatory agencies, or industry partners upon request. Requests must include a research protocol or data use justification. Data access is contingent on execution of a data use agreement (DUA) and, where applicable, institutional review board (IRB) approval. All shared data will comply with HIPAA de-identification standards (45 CFR §164.514). The U.S. Wound Registry reserves the right to review all requests for scientific merit, relevance, and feasibility. Contact the registry to initiate a data access request. For access inquiries, contact: cfife@intellicure.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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