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NCT02280733 Clinical Trial

A Real World, Observational Registry of Chronic Wounds and Ulcers

Peripheral Arterial Disease Clinical Trial

— USWR  

Official title:
A Real World, Observational Registry of Chronic Wounds and Ulcers to Assess Quality of Care, Evidence Based Practice and Outcomes Using Linked Electronic Health Record Data

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02280733
Other study ID # USWR 001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2005
Est. completion date January 2026

Study information
Verified date April 2018
Source U.S. Wound Registry
Contact Caroline E Fife, MD
Phone 800-603-7896
Email cfife@USwoundregistry.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).

Description:

This is a longitudinal, observational study of chronic wounds and ulcers treated at participating hospital based, outpatient wound centers. Data collection began in 2005. Structured data are collected at the point of care in the patient electronic health record and data from all patients at more than 100 wound centers in the USA and Puerto Rico are transmitted to the U.S. Wound Registry which is recognized by CMS as a Qualified Clinical Data Registry (QCDR). Participation in the USWR can satisfy the registry participation option for Stage 2 of Meaningful use. The dataset includes all wound and ulcer types such as diabetic foot ulcers, venous stasis ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, vasculitic ulcers, arterial ulcers, sickle cell ulcers, inflammatory ulcers (e.g. pyoderma gangrenosum), and ulcers related to skin disorders such as scleroderma. Interventions provided include advanced dressings, compression bandaging, off-loading, cellular and/or tissue based therapies, hyperbaric oxygen therapy, negative pressure wound therapy, debridement, and antibiotics. Ulcers are risk stratified for outcomes reporting using the Wound Healing Index.Outcomes measured include healing or wound closure, surgical closure, death, and major and minor amputation. Data on wound care specific quality measures developed by the QCDR are also available.

Recruitment information / eligibility
Status Recruiting
Enrollment 175000
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: All wounds in all patients at participating centers -

Exclusion Criteria: none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Usual care
advanced dressings, off-loading, venous ulcer compression, arterial screening

Locations
Country Name City State
United States US Wound Registry The Woodlands Texas

Sponsors (1)
Lead Sponsor Collaborator
U.S. Wound Registry

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Ad — View Citation

Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer off-loading: The gap between evidence and practice. Data from the US Wound Registry. Adv Skin Wound Care. 2014 Jul;27(7):310-6. doi: 10.1097/01.ASW.0000450831.65667.89. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Healed Wound closure by secondary intention 1 year
Primary Major amputation Below the knee, above the knee 1 year
Primary minor amputation toe amputation, transmetatarsal amputation, midfoot amputation 1 year
Primary death death 1 year
Secondary Wound related quality of life 1 year
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