Venous Leg Ulcer and Lymphedema Registry

Venous Stasis Ulcer Clinical Trial

— VLULR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02813187
• Other study ID #: CDR006
• Status: Enrolling by invitation
• First received: June 10, 2016
• Last updated: April 23, 2018
• Start date: May 2016
• Est. completion date: June 2025

Study information

• Verified date: April 2018
• Source: U.S. Wound Registry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Quality of Patient Care
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcer

Intervention

Biological:
• cellular and tissue based therapy

Procedure:
• debridement

• advanced wound therapy

Dietary Supplement:
• Nutritional screening

Locations

Country	Name	City	State
United States	CHI St. Luke's The Woodlands	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Wound Registry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing	wound closure	12 months
Secondary	Weeks of Therapy	days from initial visit to discharge	12 months
Secondary	Adverse events during therapy	hospitalization, cellulitis, amputation	12 months
Secondary	Patient Reported Outcome	using patient reported outcome quality measure	12 months
Secondary	Venous Insufficiency	secondary lymphedema and its relationship to venous insufficiency	12 months