Registry of Chronic Wounds and Ulcers
A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them
U.S. Wound Registry · NCT02280733
This study collects information from patients with chronic wounds and ulcers to see how well different treatments are working and to improve the quality of wound care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300000 (estimated) |
| Sex | All |
| Sponsor | U.S. Wound Registry (other) |
| Locations | 1 site (The Woodlands, Texas) |
| Trial ID | NCT02280733 on ClinicalTrials.gov |
What this trial studies
This observational registry collects structured data on patients with chronic wounds and ulcers from over 100 outpatient wound centers across the USA and Puerto Rico. The data, gathered at the point of care, includes various types of wounds such as diabetic foot ulcers, pressure ulcers, and surgical wounds. The U.S. Wound Registry, recognized as a Qualified Clinical Data Registry, aims to improve wound care quality measures and patient outcomes through comprehensive data collection and analysis. The study has been ongoing since 2005 and focuses on evaluating treatment effectiveness and adherence to established quality measures.
Who should consider this trial
Good fit: Ideal candidates for this registry include all patients with chronic wounds and ulcers treated at participating outpatient wound centers.
Not a fit: Patients who do not have chronic wounds or ulcers will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the quality of care for patients with chronic wounds, leading to improved healing outcomes.
How similar studies have performed: Other studies utilizing similar observational registry approaches have shown success in improving patient outcomes and care quality.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
The Woodlands, Texas
- US Wound Registry — The Woodlands, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Caroline E Fife, MD — Intellicure LLC
- Study coordinator: Caroline E Fife, MD
- Email: cfife@USwoundregistry.com; cfife@intellicure.com
- Phone: 800-603-7896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis, Skin Ulcer, Leg Ulcer, Pyoderma, Peripheral Arterial Disease