A Real World Observational Registry of Chronic Wounds and Ulcers

  • STATUS
    Recruiting
  • End date
    Jan 22, 2026
  • participants needed
    175000
  • sponsor
    U.S. Wound Registry
Updated on 22 January 2021
surgical wound
wound care
diabetic foot
venous stasis
wound treatment
compression therapy
foot ulceration
foot ulcer
surgical wounds
pressure ulcer
venous ulcer
diabetic foot ulcers
decubitus ulcer

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).

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.

Details
Condition Varicose Ulcer, Varices, Varicose Veins, DIABETIC NEUROPATHY, DIABETIC NEUROPATHY, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), diabetic complication, Pyoderma, Trauma, Wounds, Lymphedema, Lymphedema, Vasculitis, Vascular Diseases, Vascular Diseases, Venous stasis, Postoperative wound breakdown, Leg Ulcer, Venous Leg Ulcers, Decubitus Ulcer, Bed Sores (Decubitus Ulcers), Pressure Ulcers, Pressure Ulcer, Amputation stump, Peripheral Neuropathy, Peripheral Neuropathy, Skin Ulcer, Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, Venous Insufficiency, peripheral arterial disease, Peripheral Arterial Disease (PAD), Foot Ulcer, Ischemic Foot Ulcers, Dermatosis, Congenital Skin Diseases, Skin Conditions, Diabetic Foot, Diabetic Foot Ulcers, Circulation Disorders, Diabetes Prevention, Diabetes Mellitus Types I and II, Venous Leg Ulcers, Congenital Skin Diseases, Peripheral Arterial Disease (PAD), Diabetes (Pediatric), Bed Sores (Decubitus Ulcers), Ischemic Foot Ulcers, Skin Conditions, Varicose Veins, Wounds, Diabetic Foot Ulcers, Pressure Ulcers, Pressure Ulcer, peripheral arterial diseases, lymphoedema, diabetic complications, peripheral artery disease, lower extremity ulcers, leg ulcers, venous ulcers, venous ulcer, pressure sores, decubitus, bedsore, stump, skin ulcers, cutaneous ulcers, ulcer skin, skin sores, cutaneous ulcer, wound breakdown
Treatment Usual Care
Clinical Study IdentifierNCT02280733
SponsorU.S. Wound Registry
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All wounds in all patients at participating centers -

Exclusion Criteria

none
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