Clinical trial NCT02280733: A Real World, Observational Registry of Chronic Wounds and Ulcers
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Foot
Varicose Ulcer
Pressure Ulcer
Surgical Wound Dehiscence
Vasculitis
Skin Ulcer
Leg Ulcer
Wounds and Injuries
Pyoderma
Peripheral Arterial Disease
Diabetic Neuropathies
Lymphedema
Venous Insufficiency
Diabetes Complications
Amputation Stump
Keywords: Qualified Clinical Data Registry
Quality Measures
Meaningful Use Stage 2
Electronic Health Records
Clinical Data Research Network
Real world data
Lead sponsor: U.S. Wound Registry
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 175000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All wounds in all patients at participating centers

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria: All wounds in all patients at participating centers -

Exclusion Criteria: none

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Primary outcomes:
measure: Healed
timeFrame: 1 year
measure: Major amputation
timeFrame: 1 year
measure: minor amputation
timeFrame: 1 year
measure: death
timeFrame: 1 year
Secondary outcomes:
measure: Wound related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: The Woodlands
country: United States
facility: US Wound Registry
state: Texas
Study officials:
affiliation: U.S. Wound Registry
name: Caroline E Fife, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1089/wound.2013.0476.
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.
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.
citation: 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.
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.
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.