USWR: A Real World, Observational Registry of Chronic Wounds and Ulcers

Sponsor

U.S. Wound Registry (Other)

Overall Status

Recruiting

CT.gov ID

NCT02280733

Collaborator

(none)

175,000

Enrollment

Location

252

Anticipated Duration (Months)

694.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
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	Other: Usual care

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

175000 participants

Observational Model:

Other

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 1, 2005

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Outcome Measures

Primary Outcome Measures

Healed [1 year]
Wound closure by secondary intention
Major amputation [1 year]
Below the knee, above the knee
minor amputation [1 year]
toe amputation, transmetatarsal amputation, midfoot amputation
death [1 year]
death