Venous Leg Ulcer and Lymphedema Registry

• Conditions: Venous Stasis Ulcer; Quality of Patient Care

• Registration Number: NCT02813187
• Lead Sponsor: U.S. Wound Registry

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound Healing	12 months	wound closure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHI St. Luke's The Woodlands; 🇺🇸 The Woodlands, Texas, United States