Actively Recruiting

All Genders
ID02280733

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

Led by U.S. Wound Registry ยท Updated on 2025-07-16

300000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

CONDITIONS

Brief Title

A Real-World Registry of Chronic Wounds and Ulcers

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of one or more chronic wounds or ulcers of any cause
  • Wound or ulcer must be treated at a participating healthcare site such as hospital outpatient, office, mobile practitioner, home, or skilled nursing
  • Care must be documented using the specialized wound-specific electronic health record or data capture system
  • All ages are eligible, including infants and patients aged 90 years or older
  • All sexes and gender identities are eligible
  • All wound types and severities are included, with possible multiple wounds per patient
Not Eligible

You will not qualify if you...

  • None; the registry includes all eligible patients treated at participating sites without any exclusions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years or longer

Participants who undergo routine care for chronic wounds and ulcers are observed. Data are collected during routine clinical visits using a specialized wound-specific electronic health record system.

Ongoing visits during routine care as needed

Trial Site Locations

Total: 1 location

1

US Wound Registry

The Woodlands, Texas, United States, 77386

Actively Recruiting

Loading map...

Research Team

C

Caroline E Fife, MD

B

Ben LeBoutillier, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

A Multicenter, Prospective, Clinical Trial Evaluating a Sing...

Pressure Ulcer

Actively Recruiting

1 location

A Multicenter, Prospective, Controlled Clinical Trial Evalua...

Diabetic Foot

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting.

Caroline E Fife, David Walker, Brett Thomson...

https://pubmed.ncbi.nlm.nih.gov/18577134

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.

Marissa J Carter, Caroline E Fife, David Walker...

https://pubmed.ncbi.nlm.nih.gov/20375969