NCT02813187

Venous Leg Ulcer and Lymphedema Registry

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: U.S. Wound Registry · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Stasis Ulcer
• Quality of Patient Care

Interventions

Type	Name	Description
BIOLOGICAL	cellular and tissue based therapy
PROCEDURE	debridement
PROCEDURE	advanced wound therapy
DIETARY_SUPPLEMENT	Nutritional screening

Timeline

• Start date: 2016-05-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2016-06-24
• Last updated: 2018-04-25

Locations

1 site across 1 country: United States