Clinical Trial: A Real World, Observational Registry of Chronic Wounds and Ulcers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
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
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 Summary: 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.
Sponsor: U.S. Wound Registry
Current Primary Outcome:
- Healed [ Time Frame: 1 year ]Wound closure by secondary intention
- Major amputation [ Time Frame: 1 year ]Below the knee, above the knee
- minor amputation [ Time Frame: 1 year ]toe amputation, transmetatarsal amputation, midfoot amputation
- death [ Time Frame: 1 year ]death
Original Primary Outcome: Same as current
Current Secondary Outcome: Wound related quality of life [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: U.S. Wound Registry
Dates:
Date Received: October 29, 2014
Date Started: January 2005
Date Completion: January 2026
Last Updated: May 18, 2016
Last Verified: May 2016
