A Real World, Observational Registry of Chronic Wounds and Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All wounds in all patients at participating centers - Exclusion Criteria: none -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Usual care|advanced dressings, off-loading, venous ulcer compression, arterial screening|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| death | death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound related quality of life |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qualified Clinical Data Registry, Quality Measures, Meaningful Use Stage 2, Electronic Health Records, Clinical Data Research Network, Real world data