A Real-World Registry of Chronic Wounds and Ulcers

NCT02280733 | Recruiting DMC

• 1 other identifier: USWR 001
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

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; 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

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

Outcome Measures

Primary Outcomes (4)

• Healed

  Wound closure by secondary intention

  1 year

• Major amputation

  Below the knee, above the knee

  1 year

• Minor amputation

  toe amputation, transmetatarsal amputation, midfoot amputation

  1 year

• Patient Death

  patient death while in treatment

  1 year

Secondary Outcomes (1)

• Percent surface area (PAR) reduction over time

  variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 52 weeks)

Study Arms (1)

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

Interventions

Usual care OTHER

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

Also known as: usual and customary care

chronic wound patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• U.S. Wound Registry: lead

Study Sites (1)

US Wound Registry

The Woodlands, Texas, 77386, United States

RECRUITING

Related Publications (6)

• Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.

  PMID: 18577134 BACKGROUND

• Fife CE, Walker D, Thomson B. Electronic Health Records, Registries, and Quality Measures: What? Why? How? Adv Wound Care (New Rochelle). 2013 Dec;2(10):598-604. doi: 10.1089/wound.2013.0476.

  PMID: 24761335 BACKGROUND

• Horn SD, Fife CE, Smout RJ, Barrett RS, Thomson B. Development of a wound healing index for patients with chronic wounds. Wound Repair Regen. 2013 Nov-Dec;21(6):823-32. doi: 10.1111/wrr.12107. Epub 2013 Oct 17.

  PMID: 24134202 BACKGROUND

• Carter MJ, Fife CE, Walker D, Thomson B. Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials. Adv Skin Wound Care. 2009 Jul;22(7):316-24. doi: 10.1097/01.ASW.0000305486.06358.e0.

  PMID: 20375969 BACKGROUND

• Fife CE, Carter MJ, Walker D, Thomson B. A retrospective data analysis of antimicrobial dressing usage in 3,084 patients. Ostomy Wound Manage. 2010 Mar 1;56(3):28-42.

  PMID: 20368672 BACKGROUND

• Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Repair Regen. 2010 Mar-Apr;18(2):154-8. doi: 10.1111/j.1524-475X.2010.00571.x. Epub 2010 Feb 16.

  PMID: 20163568 BACKGROUND

Related Links

• US Wound Registry Website

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer; Surgical Wound Dehiscence; Vasculitis; Skin Ulcer; Leg Ulcer; Pyoderma; Peripheral Arterial Disease; Lymphedema; Calciphylaxis; Varicose Ulcer; Pyoderma Gangrenosum

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Varicose Veins; Skin Diseases, Vascular

Study Officials

• Caroline E Fife, MD

  Intellicure LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline E Fife, MD

CONTACT

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

Ben LeBoutillier, MS

CONTACT

800-603-7896; bLeBoutillier@intellicure.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: January 1, 2005
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• 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.
• 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

Locations

US (1)