ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02280733
Recruitment Status : Recruiting
First Posted : October 31, 2014
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
U.S. Wound Registry

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
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 Type : Observational [Patient Registry]
Estimated Enrollment : 175000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
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 : January 2005
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Usual care
    advanced dressings, off-loading, venous ulcer compression, arterial screening
    Other Name: usual and customary care


Primary Outcome Measures :
  1. Healed [ Time Frame: 1 year ]
    Wound closure by secondary intention

  2. Major amputation [ Time Frame: 1 year ]
    Below the knee, above the knee

  3. minor amputation [ Time Frame: 1 year ]
    toe amputation, transmetatarsal amputation, midfoot amputation

  4. death [ Time Frame: 1 year ]
    death


Secondary Outcome Measures :
  1. Wound related quality of life [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All wounds in all patients at participating centers
Criteria

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

Exclusion Criteria: none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280733


Contacts
Contact: Caroline E Fife, MD 800-603-7896 cfife@USwoundregistry.com
Contact: Monica Weir, MBA, CCRP 800-603-7896 monica.weir@uswoundregistry.com

Locations
United States, Texas
US Wound Registry Recruiting
The Woodlands, Texas, United States, 77381
Contact: Monica Weir, MBA, CCRP    800-603-7896    monica.weir@uswoundregistry.com   
Sponsors and Collaborators
U.S. Wound Registry
Investigators
Principal Investigator: Caroline E Fife, MD U.S. Wound Registry

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: U.S. Wound Registry
ClinicalTrials.gov Identifier: NCT02280733     History of Changes
Other Study ID Numbers: USWR 001
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by U.S. Wound Registry:
Qualified Clinical Data Registry
Quality Measures
Meaningful Use Stage 2
Electronic Health Records
Clinical Data Research Network
Real world data

Additional relevant MeSH terms:
Pressure Ulcer
Wounds and Injuries
Ulcer
Diabetic Foot
Peripheral Arterial Disease
Peripheral Vascular Diseases
Lymphedema
Diabetic Neuropathies
Leg Ulcer
Vasculitis
Surgical Wound
Venous Insufficiency
Diabetes Complications
Pyoderma
Varicose Ulcer
Skin Ulcer
Surgical Wound Dehiscence
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Skin Diseases
Diabetes Mellitus
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Lymphatic Diseases
Peripheral Nervous System Diseases