VLULR: Venous Leg Ulcer and Lymphedema Registry

Sponsor

U.S. Wound Registry (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02813187

Collaborator

(none)

10,000

Enrollment

Location

109

Anticipated Duration (Months)

91.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Venous Stasis Ulcer Quality of Patient Care	Biological: cellular and tissue based therapy Procedure: debridement Procedure: advanced wound therapy Dietary Supplement: Nutritional screening

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

Wound Healing [12 months]
wound closure

Secondary Outcome Measures

Weeks of Therapy [12 months]
days from initial visit to discharge
Adverse events during therapy [12 months]
hospitalization, cellulitis, amputation
Patient Reported Outcome [12 months]
using patient reported outcome quality measure
Venous Insufficiency [12 months]
secondary lymphedema and its relationship to venous insufficiency