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Venous Leg Ulcer and Lymphedema Registry

A Real World, Observational Registry of Venous Leg Ulcers and Quality of Care in Clinical Practice

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02813187
Acronym
VLULR
Enrollment
10000
Registered
2016-06-24
Start date
2016-05-31
Completion date
2025-06-30
Last updated
2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Stasis Ulcer, Quality of Patient Care

Keywords

venous leg ulcer, venous, QCDR, quality measure, wound, Outcome, Lymphedema

Brief summary

This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

Detailed description

This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National bench marking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

Interventions

Sponsors

U.S. Wound Registry
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients with venous leg ulcers seen by the practitioner.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Wound Healing12 monthswound closure

Secondary

MeasureTime frameDescription
Weeks of Therapy12 monthsdays from initial visit to discharge
Adverse events during therapy12 monthshospitalization, cellulitis, amputation
Patient Reported Outcome12 monthsusing patient reported outcome quality measure
Venous Insufficiency12 monthssecondary lymphedema and its relationship to venous insufficiency

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026